Quality & Compliance Specialist (CSV, GMP, GCP)

Roche; Petaling Jaya; On-site; MYR 60,000 - 90,000; Full time

Job summary

Roche is seeking a Quality Assurance professional committed to ensuring compliance and quality across IT systems. This role includes collaboration with stakeholders to maintain and improve regulatory standards, ensuring that solutions align with the evolving needs of healthcare. Join Roche to influence and impact the quality of healthcare solutions for a healthier future.

Qualifications

• Exhibits servant and creative leadership behavior.
• Demonstrates knowledge of FDA, GxP and risk control frameworks.

Responsibilities

• Ensure compliance with regulatory standards for IT systems.
• Collaborate to develop Product Roadmap and Quality Assurance oversight.
• Manage product service levels and operational support.

Skills

Quality Assurance

Regulatory Compliance

Product Management

Leadership

Lean-Agile Mindset

Intellectual Curiosity

Education

Understanding of health regulatory frameworks

Experience with control automation

Job description

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.

The Position Our ambition is to empower Integrated Informatics to deliver quality and compliance in an efficient way, right the first time.

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

Who we are

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.