185 Compliance Specialist jobs in Malaysia

AIA Malaysia Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

AIA Malaysia Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

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At AIA we’ve started an exciting movement to create a healthier, more sustainable future for everyone.

It’s about finding new ways to not only better people's lives, but to better the communities and environments we live in. Encompassing our ambition of helping a billion people live Healthier, Longer, Better Lives by 2030.

And to get there, we need ambitious people who believe in playing an important part in shaping that future. People seeking unmatched career and personal growth opportunities, who are driven to work with, and learn from some of the most inspiring and supportive leaders in the business.

Sound like you? Then read on.

About The Role

Responsible to provide support to the registered Compliance Officer of APAM and work as a second line of defense in partnership with the business (as first line of defense) to ensure that all regulatory and market conduct risk is efficiently and effectively assessed, mitigated and controlled and that a culture of ethics and compliance is developed and maintained in respect of the organization’s business in support of APAM’s profitability and sustainable growth objectives.

Implementation of compliance program

• Support the implementation and ongoing enhancement of the APAM's Compliance Program that is focused on Anti-Money Laundering ("AML"), regulatory, investments, product and sales (market conduct) compliance, whilst ensuring its alignment with business objectives, AIA Group Operating Principles and Group Compliance's strategic direction.
• Support the implementation of an effective compliance risk assessment program for APAM and engage with key business stakeholders.

Implementation of culture of compliance and ethics programs

• Implement an effective education program through ongoing communication and training to embed a culture of compliance and ethics within APAM.

Reporting and monitoring (as second line of defense)

• Responsible for the effective communication of compliance matters including timely and accurate reporting and/or escalation of such matters in accordance with relevant reporting and escalation protocols, including regular reporting to the registered Compliance Officer of APAM on compliance risk, issues and activities.
• Responsible to perform compliance reviews on business units, departments and branches/sales offices.
• Support the development of structural approach and procedures to effectively deal with suspected instances of compliance policy violations by employees and/or fraud and misappropriations by intermediaries, from receiving allegations to planning and conducting investigations.

Others

• Perform other responsibilities and duties periodically assigned by the supervisor/APAM Compliance Officer in order to meet operational and/or other requirements.

Job Requirements

• Bachelor’s degree in Accounting, Finance, Law or Business with 5 years solid work experience in the financial industry handling compliance and/or controls.
• Preferably passed Module 9 (Funds Management Regulation), Module 10 (Asset and Funds Management) and Module 11 (Fundamentals of Compliance) of Securities Commission Malaysia Licensing Examination.
• In-depth understanding of the fund management business and regulatory development, in lieu of financial services.
• Good interpersonal and communication skills and self-motivated.
• Good written and spoken communication skills in English and local language.
• Independent and be able to work under pressure.
• Be organized, detail-oriented and analytical.
• Possess leadership, coaching and influencing skills; business acumen; problem solving skills.
• High level of integrity and take ownership and accountability of results.

Build a career with us as we help our customers and the community live Healthier, Longer, Better Lives.

You must provide all requested information, including Personal Data, to be considered for this career opportunity. Failure to provide such information may influence the processing and outcome of your application. You are responsible for ensuring that the information you submit is accurate and up-to-date.

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Finance and Sales
• Industries Insurance

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The Quality Compliance Specialist investigate customer complaints, make initial reporting decisions, facilitate investigations, and ensure completeness and consistency of the documentation for complaints.

Duties & Responsibilities:

• Responsible for quality compliance duties relating to customer complaints, including but not limited to preliminary classification of complaints, customer and product follow ups, maintaining investigation records and all other supporting documentations, and assign additional actions as necessary to close complaint.
• Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics.
• Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; Elevate complaints that require additional review for regulatory reporting.
• Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate additional complaint records to document all of the issues listed in the complaint description.
• Ensure that all complaints requiring customer responses are properly addressed, as assigned; drafts and documents the response in the complaint file.
• Requests information from the customer related to complaint including the return of product(s) that are part of a system (i.e. sensor-cable-monitor).
• Review QPM trends related to complaints for potential trend.
• Ensures applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.
• Evaluates each complaint if an investigation is required or not. Where investigation is needed, determine timelines with Failure Analysis Lab to ensure timely evaluation of product complaints and timely completion of reports. Reviews complaint investigation reports to ensure investigations are thorough and adequate and in accordance with procedures.
• Executes duties in compliance with established company policies.
• Develops a thorough understanding of the complaint database.
• Perform other duties or special projects as assigned.

Minimum Qualifications and Experience:

Minimum Qualifications:

• Ability to follow instructions and procedures and prioritize tasks.
• Ability to compile information, summarize, and input into quality database.
• Ability to interact effectively with internal and external stakeholders through phone calls, emails, and video meetings.
• Fluent in English in writing and verbal communications.
• Experience in Microsoft Suite applications.
• Highly organized and self-motivated individuals.
• Skills required:
• Strong computer skills and expertise in Microsoft office applications and charting programs.
• Ability to interact effectively on a team and with internal and external customers.
• Demonstrated excellent technical writing and verbal communication skills.
• Demonstrated independent worker with ability to focus, and able to prioritize and handle multiple tasks and responsibilities.
• Must be a self-starter, a “hands-on” individual who enjoys challenge and is dedicated to getting the job done with minimal and/or no direction.
• Demonstrated attention to detail, strong results orientation, positive “can do” attitude, and a sense of urgency to get things done.
• Logical approach to decision making.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a validDriver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Masimo is proud to be an EOE/, M/F/D/V, and we are committed to Diversity at every level

Job Summary:

An Incoming Quality Engineer plays a critical role in ensuring that incoming materials and components meet established quality standards and specifications. They are responsible for implementing processes and procedures to assess, inspect, and validate incoming materials for use in manufacturing processes. The role requires a combination of technical expertise, analytical skills, and a commitment to maintaining high standards of quality throughout the supply chain.

Duties & Responsibilities:

• Conduct thorough inspections of incoming materials and components to ensure they meet established quality standards, specifications, and regulatory requirements.
• Maintain accurate records of inspection results, test data, and any deviations from quality standards. Collect & maintain COC and all docs related to incoming material.
• Document non-conforming materials and initiate appropriate corrective actions.
• Collaborate with the supplier quality team to address quality issues, improve incoming material quality, and establish effective communication channels for resolving quality-related concerns.
• Ensure, through training and verification, the appropriate use of current documentation, as well as the use of good documentation practices during all the stages of manufacturing.
• Ensure and monitor the applicable documents for Quality inspection are available in the point of use, including visual aids with physical samples.
• Continuously assess and improve incoming quality inspection processes to enhance efficiency, accuracy, and reliability. Identify opportunities for automation and optimization to streamline workflows.
• Provide training and guidance to employees involved in the incoming quality inspection process. Ensure that team members understand quality standards, inspection procedures, and best practices.
• Ensure that all Inspection Equipment that requires calibration is calibrated.
• Assist in Quality System activities such as following the PDA process, Internal Audits, Internal Observations, Document Control, and providing data for reports.
• Actively participate in continuous improvement initiatives aimed at enhancing overall product quality, customer satisfaction, and operational excellence.
• Any reasonable task assigned by Superior from time to time.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• Minimum experience of 3 years in Incoming Quality.
• Good English communication skills, written and speaking.
• Previous experience in quality engineering, supplier quality management, or a related role within a manufacturing environment.
• Ability to perform measurement hands-on using simple hand tools, microscope, and Image measuring system.
• Excellent communication skills and the ability to collaborate effectively with internal and external teams.
• Analytical mindset with strong problem-solving skills and attention to detail.
• Experience with root cause analysis, corrective and preventive action (CAPA) processes, and risk management methodologies.

Preferred Qualifications:

• Proficiency in Microsoft Office knowledge.
• Experience in Risk Management to ISO 14971 and IEC 60601-1, 3rd Edition, ISO13485, and FDA regulations (will be added advantage).
• Strong knowledge of quality management principles, statistical analysis, and quality inspection techniques.
• Certified as an ISO internal auditor should be advantageous.

Education:

Bachelor’s degree in engineering is required and/or other related equivalent.

Physical requirements/Work Environment:

This position works in office, laboratory, and manufacturing environments. It requires frequent sitting, standing, and walking. The candidate needs to be able to recognize and differentiate color. They must also be able to lift up to 50 pounds. Daily use of computer and other computing and digital devices is required. The candidate may stand for extended periods when facilitating meetings, walking in the facilities, performing audits, and laboratory testing. The ability to operate a motor vehicle and maintain a valid driver license is required.

The physical demands of the position described herein are essential functions of the job, and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

I need a mid-level accountant to help with compliance for my startup (Sdn Bhd) with no business or income last financial year.

Key tasks include:
– Assisting in preparing management accounts
– Compiling unaudited/audited financial statements
– Circulating financial statements to SSM
– Filing tax return (YA 2024) with LHDN

Ideal skills and experience:
– Proficient in Malaysian accounting regulations
– Experience with SSM and LHDN submissions

Freelancing Managed by Heyram Solutions 201103052949 (PG0278884-P)

XTransfer Federal Territory of Kuala Lumpur, Malaysia

XTransfer Federal Territory of Kuala Lumpur, Malaysia

Direct message the job poster from XTransfer

Monthly Rotating Shifts (Morning, Noon, Night) — Night Shift is Work-from-Home

Why XTransfer?

• No.1 B2B Cross-border Payment Platform
• Supportive Work Culture
• Career Growth in a Blooming Fintech Industry

Role Overview:

Safeguard our cross-border payment platform by ensuring compliance, preventing fraud and protecting clients. You will review customer data, assess risks and work closely with clients to resolve compliance issues.

Job Responsibilities:

• Review and verify KYC documents (e.g., IDs, business licenses) against anti-fraud and sanctions databases, ensuring timely case resolution within SLA
• Conduct sanctions screening and identify politically exposed persons (PEPs) or high-risk entities in line with international requirements
• Proactively communicate with clients to resolve incomplete or flagged submissions via multilingual channels (primarily English)
• Analyze recurring risk patterns and contribute insights to the risk knowledge base
• Perform merchant due diligence: assess business models, transaction histories, and ownership structures to assign appropriate risk tiers
• Stay up to date with AML/CTF regulations and ensure all processes meet legal and policy standards

Job Requirements:

• Bachelor’s degree in Business, Finance, Law, or relevant field (preferred)
• 1–5 years' working experience in compliance, risk management or cross-border payments risk control (e-commerce/fintech preferred)
• Excellence attention to detail
• Strong analytical and data skills (Excel/ SQL) with the ability to model risk logically
• Fluency in English is required; Mandarin is a PLUS
• Willing to work on a Monthly Rotating Shift Schedule (Morning, Noon, Night) — Night shift is Work-from-Home

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Finance, Accounting/Auditing, and General Business

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Razer Inc. Bangsar South, Federal Territory of Kuala Lumpur, Malaysia

Join to apply for the Senior IT Risk & Compliance Specialist role at Razer Inc.

Razer Inc. Bangsar South, Federal Territory of Kuala Lumpur, Malaysia

Join to apply for the Senior IT Risk & Compliance Specialist role at Razer Inc.

Joining Razer will place you on a global mission to revolutionize the way the world games. Razer is a place to do great work , offering you the opportunity to make an impact globally while working across a global team located across 5 continents. Razer is also a great place to work, providing you the unique, gamer-centric experience that will put you in an accelerated growth, both personally and professionally.

Job Responsibilities

The IT Risk & Compliance role is responsible for assessing, analyzing, and mitigating potential risks within an organization’s IT infrastructure and systems, ensuring adherence to relevant regulations, standards, and policies.

Requirements

• Bachelor’s degree in computer science, information technology, or equivalent.
• Minimum of 4 years of experience in IT compliance, regulatory affairs, or a similar role.
• In-depth understanding of IT regulations, standards, and frameworks globally (e.g., MAS TRM, RMiT, ISO 27001, GDPR, BOT).
• At least 4 years of hands-on experience in technical security risk assessment, with industry certifications such as CRISC, CISA, and CISM being advantageous.
• Knowledge of information security risks, Strong written and oral communication skills. The ability to communicate effectively (clear, concise and professionally).
• Exceptional communication skills to convey complex compliance requirements to various stakeholders.
• Ability to collaborate effectively with cross-functional teams.
• Passionate about maintaining software compliance policies, regulatory landscapes, and IT risk assessments.
• Skilled in creating and maintaining compliance documentation and reports.
• Detail-oriented with a focus on accuracy and completeness.
• Knowledge of cloud infrastructure (AWS, Azure, etc.) would be an advantage.
• Knowledge of any structured query language programming (MSSQL, MYSQL) would be an advantage.
• Fluent in Thai would be an advantage.
• Working knowledge or interest in technology infrastructure principles and practices.
• Good working attitude and a strong team player.
• Excellent communication and presentation skills.
• Positive attitude and an eagerness to learn with minimal supervision.
  
  
  

• Develop and manage IT risk and security for multiple IT functional areas (e.g., applications, systems, network, and Web) across the enterprise.
• Identify vulnerabilities, implement security measures, and develop strategies to safeguard against threats such as cyber-attacks, data breaches, and system failures.
• Conduct and facilitate IT and cyber risk assessments covering IT general controls, application controls, IT security reviews, and monitor activities with risk owners/representatives. Evaluate internal IT controls and identify opportunities for improvement.
• Oversee technical risk assessments related to data, including data leaks, data loss, risks to customers, vulnerability scanning, and penetration testing.
• Maintain processes to ensure only approved software versions are deployed to the production environment.
• Work with engineering teams to ensure software solutions conform to regulatory requirements.
• Evaluate software development, testing, and release procedures to meet regulatory specifications where applicable.
• Stay informed of industry best practices, changes, and trends, and assess the potential impact of these changes.
• Assist in the implementation of Business Continuity Planning annual exercises.
  
  
  

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• Collaborate with various teams and auditors to ensure compliance with industry standards and regulations, conduct risk assessments, and propose solutions to minimize risks while maintaining operational efficiency.
• Respond to inquiries regarding compliance regulations, rules, policies, procedures, and current technical compliance status.
• Serve as a central point for IT governance and compliance, manage IT risk, oversee quality and performance metrics, and provide business support.
• Manage, develop, and periodically maintain documentation required to support all IT risk, governance, and technical regulatory requirements.
• Assist in developing and implementing compliance programs, policies, and procedures to mitigate risks and maintain data integrity and security.
• Reviewing audit reports and other documents produced by internal auditors or external auditors to determine if corrective actions are necessary
• Work closely with IT to perform IT due diligence on third-party service providers and reports.
• Coordinate technical audit exercises with internal and external auditors.
  
  
  

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Information Technology
• Industries Computers and Electronics Manufacturing

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Quality & Compliance Specialist (CSV, GMP, GCP) page is loadedQuality & Compliance Specialist (CSV, GMP, GCP) Candidatar-se locations Petaling Jaya Warsaw time type Tempo integral posted on Publicado há 2 dias job requisition id 202506-115071

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle. You are a customer-focused, highly collaborative individual who will work with delivery units across both Business and Informatics to advance existing and emerging business critical technology according to Roche’s needs

WHAT YOU’LL BE WORKING ON

You will assure that Roche’s regulated/critical systems and services adhere to regulatory standards (e.g. CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business. By providing automated control insights and streamlined monitoring capabilities, an effective and consistent tracking of Information on Quality Oversight is enabled. Governance and processes are provided to comply with GxP, Data privacy laws and regulations when processing and hosting Roche data.

• Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV). Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards. Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements

• Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems. Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution

• Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas

STAKEHOLDER MANAGEMENT AND PARTNERING:

• Connect and understand the regulatory and compliance needs in the context of the stakeholders and closely partner with them to develop the strategic direction of the product. Shape the Digitalized Compliance roadmap and portfolio to deliver high value outcomes for the customers of the product. Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes

• Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices

• Coordinate, connect and collaborate across informatics to foster a spirit of "One Roche"

IMPACT AND COMPLEXITY

• Define and manage product service levels, governance and operational support model aligned with stakeholder needs . Lead or coordinate quality and compliance discussions. Ensure stability, quality and transparency in all aspects of the product governance and partner with senior/global leaders to ensure compliance with existing and changing regulations

• Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements . Ensure that services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements.Ensure information risk assessment process and implementation guidelines are followed

What you’ll need to be successful

• Exhibits servant and creative leadership (VACC) behavior. Exhibits a Lean-Agile Mindset and excels at Product Management practices. Takes 'progressive risk'--not thrill-seeking, but risk that leads to opportunity

• Has a keen Quality & Regulatory focus: You are passionate about major trends . Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity

• Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.

• Exhibits ability to empower teams and individuals to act autonomously and hold them accountable . Exhibits intellectual curiosity and integrity and has a strong passion for innovation

• Understanding of health regulatory frameworks (FDA, GxP); Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR, experience with control automation

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle. You are a customer-focused, highly collaborative individual who will work with delivery units across both Business and Informatics to advance existing and emerging business critical technology according to Roche’s needs

WHAT YOU’LL BE WORKING ON

You will assure that Roche’s regulated/critical systems and services adhere to regulatory standards (e.g. CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business. By providing automated control insights and streamlined monitoring capabilities, an effective and consistent tracking of Information on Quality Oversight is enabled. Governance and processes are provided to comply with GxP, Data privacy laws and regulations when processing and hosting Roche data.

• Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards.Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements

• Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems. Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution

• Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas

STAKEHOLDER MANAGEMENT AND PARTNERING:

• Connect and understand the regulatory and compliance needs in the context of the stakeholders and closely partner with them to develop the strategic direction of the product. Shape the Digitalized Compliance roadmap and portfolio to deliver high value outcomes for the customers of the product.Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes

• Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices

• Coordinate, connect and collaborate across informatics to foster a spirit of "One Roche"

IMPACT AND COMPLEXITY

• Define and manage product service levels, governance and operational support model aligned with stakeholder needs. Lead or coordinate quality and compliance discussions. Ensure stability, quality and transparency in all aspects of the product governance and partner with senior/global leaders to ensure compliance with existing and changing regulations

• Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements. Ensure that services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements.Ensure information risk assessment process and implementation guidelines are followed

What you’ll need to be successful

• Exhibits servant and creative leadership (VACC) behavior. Exhibits a Lean-Agile Mindset and excels at Product Management practices. Takes 'progressive risk'--not thrill-seeking, but risk that leads to opportunity

• Has a keen Quality & Regulatory focus: You are passionate about major trends. Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity

• Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.

• Exhibits ability to empower teams and individuals to act autonomously and hold them accountable. Exhibits intellectual curiosity and integrity and has a strong passion for innovation

• Understanding of health regulatory frameworks (FDA, GxP); Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR, experience with control automation

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle. You are a customer-focused, highly collaborative individual who will work with delivery units across both Business and Informatics to advance existing and emerging business critical technology according to Roche’s needs

WHAT YOU’LL BE WORKING ON

You will assure that Roche’s regulated/critical systems and services adhere to regulatory standards (e.g. CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business. By providing automated control insights and streamlined monitoring capabilities, an effective and consistent tracking of Information on Quality Oversight is enabled. Governance and processes are provided to comply with GxP, Data privacy laws and regulations when processing and hosting Roche data.

• Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards. Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements

• Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems. Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution

• Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas

STAKEHOLDER MANAGEMENT AND PARTNERING:

• Connect and understand the regulatory and compliance needs in the context of the stakeholders and closely partner with them to develop the strategic direction of the product. Shape the Digitalized Compliance roadmap and portfolio to deliver high value outcomes for the customers of the product. Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes

• Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices

• Coordinate, connect and collaborate across informatics to foster a spirit of "One Roche"

IMPACT AND COMPLEXITY

• Define and manage product service levels, governance and operational support model aligned with stakeholder needs . Lead or coordinate quality and compliance discussions. Ensure stability, quality and transparency in all aspects of the product governance and partner with senior/global leaders to ensure compliance with existing and changing regulations

• Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements . Ensure that services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements.Ensure information risk assessment process and implementation guidelines are followed

What you’ll need to be successful

• Exhibits servant and creative leadership (VACC) behavior. Exhibits a Lean-Agile Mindset and excels at Product Management practices. Takes 'progressive risk'--not thrill-seeking, but risk that leads to opportunity

• Has a keen Quality & Regulatory focus: You are passionate about major trends . Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity

• Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.

• Exhibits ability to empower teams and individuals to act autonomously and hold them accountable . Exhibits intellectual curiosity and integrity and has a strong passion for innovation

• Understanding of health regulatory frameworks (FDA, GxP); Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR, experience with control automation

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.