Roche
Pharmaceutical
ValidationLead-RDTPharmaTechnicalOperations
Neural analysis suggests this role is
optimal for Mid candidates.
“Validation Lead - RDT Pharma Technical Operations at Roche. Skills: Validation Lifecycle Ownership, Risk-Based Validation, Computer System Validation, Computer System Assurance. Lead end-to-end CSV/CSA activities for GMP-critical PTD systems. Ensure systems are validated, maintained, and audit-ready”
What You'll Achieve.
Ensure systems are fit for purpose; Maintain continuity of the validated state; Ensure timely closure of CAPAs; Ensure ongoing compliance
Industry & Context.
Analytical skills
What They're Looking For.
Must Have
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, 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, 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
What You'll Do.
Lead end-to-end CSV/CSA activities for GMP-critical PTD systems
Ensure systems are validated
Apply risk-based approach to validation strategies
Ensure validation documentation is captured and transitioned
Define and review test strategies
Assess validation impact of system changes
Support deviation investigations and CAPA definition
Act as CSV SME during audits and inspections
Conduct and support system periodic reviews
How You'll Work.
Team & Collaboration
Collaborate with product owners and technical teams on test strategies; Work closely with PTD business stakeholders, Technical Product Owners, Delivery Services Managers, Quality Assurance, and MSP vendors; Embed a culture of compliance and quality across all delivery activities; Work effectively across diverse cultures, functions, and seniority levels
Communication Scope
English language fluency is mandatory
Process & Methodology
Lead validation workstreams across multiple systems simultaneously
Full 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 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
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