Petaling Jaya, Selangor, Malaysia
Onsite
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.
At Roche, compliance is our license to operate. As a Validation Lead within RDT Pharma Medicines TechOps, you will play a critical role in ensuring that the digital systems supporting Pharma Technical Development (PTD) meet the highest standards of quality, regulatory compliance, and patient safety. You will be the validation subject matter expert across a portfolio of GMP-critical systems transitioning from PTD to RDT TechOps – owning the end-to-end validation lifecycle and ensuring our systems remain audit-ready, compliant, and fit for purpose.
In everything we do, we think about patients.
Your work will directly support the integrity of processes that bring medicines to patients around the world.
The Opportunity
In this role, you will be responsible for:
Validation Lifecycle Ownership: Lead the end-to-end Computer System Validation (CSV) and Computer System Assurance (CSA) activities for GMP-critical PTD systems, including validation planning, protocol development, execution oversight, and report approval – ensuring systems are validated, maintained, and audit-ready throughout their lifecycle.
Risk-Based Validation: Apply a risk-based approach to validation, determining appropriate validation strategies, deliverables, and testing coverage for each system based on its GxP classification, business criticality, and regulatory impact.
Knowledge Transfer Support: Ensure validation documentation, system histories, and compliance records are properly captured and transitioned as part of the PTD to RDT TechOps knowledge transfer, maintaining continuity of the validated state.
Testing Strategy & Quality Oversight: Define and review test strategies, test plans, and test reports in collaboration with product owners and technical teams. Provide consultancy on test-related deviations, corrective actions, and preventive measures.
Change Control & System Maintenance: Assess the validation impact of system changes, enhancements, and patches – ensuring that the validated state is preserved across all system updates and that change control processes are followed in accordance with Roche SOPs.
Deviation & CAPA Management: Support deviation investigations to identify root causes and define corrective and preventive actions (CAPAs), ensuring timely closure and regulatory compliance.
Audit & Inspection Readiness: Act as the CSV subject matter expert during internal audits and regulatory inspections, supporting preparation, execution, and response activities for assigned systems.
Periodic Reviews: Conduct and support system periodic reviews in accordance with Roche procedures, ensuring ongoing compliance and fitness for purpose.
Stakeholder Collaboration: Work closely with PTD business stakeholders, Technical Product Owners, Delivery Services Managers, Quality Assurance, and MSP vendors to embed a culture of compliance and quality across all delivery activities.
Who you are
You are a detail-oriented compliance professional with deep expertise in GxP-regulated digital environments and a pragmatic, risk-based approach to validation. You bring:
A Bachelor's degree or equivalent in Computer Science, Life Sciences, Engineering, or a related field.
Minimum 5 years of experience in IT and software validation (CSV/CSA, GAMP) within the pharmaceutical, biotech, or life sciences industry.
Proven experience leading validation activities across GMP-regulated computerized systems, including system implementation, maintenance, and change control.
Strong knowledge of applicable regulatory frameworks and GxP practices.
Solid understanding of system and data risk assessment principles.
Experience collaborating with cross-functional Agile teams and familiarity with Agile delivery methodologies (Scrum, SAFe, or equivalent).
Ability to work independently and lead validation workstreams across multiple systems simultaneously.
Strong analytical, documentation, and communication skills – English language fluency is mandatory.
A collaborative mindset with the ability to work effectively across diverse cultures, functions, and seniority levels.
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.
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