Developing innovative IVD tests with LC - MS technology at Roche. Focused on automated methods for sample preparation and analytics.
About the role
- Director of Quality Assurance leading quality across full value chain for late-stage ophthalmic program. Collaborating with Quality, Regulatory, Technical, and Supply Chain teams to drive compliance and excellence.
Responsibilities
- Lead quality across the full value chain for a late-stage ophthalmic program
- Own the product’s quality strategy, aligned to supply strategy, and ensure clear documentation and execution
- Shape the analytical strategy (labs, testing approaches, stability) and support site selection
- Provide hands‑on quality leadership to product and focus teams; advise, problem‑solve, and drive continuous improvement
- Implement and oversee fit‑for‑purpose Quality Management Systems and standard ways of working
- Stay current on regulations and apply them pragmatically; support inspections and champion ongoing inspection readiness
- Partner with Corporate Quality and other sites to share best practices and align on quality systems
- Lead quality communications across the network; run meetings, surface risks, and escalate issues when needed
- Track and interpret key metrics (changes, complaints, annual product reviews) to identify trends and mitigate risk
- Review and approve cross‑site evaluations and post‑marketing assessments
- Monitor franchise quality risks and performance with site quality teams
- Represent Quality on the Value Chain Management Team and related working groups; lead or contribute to chartered projects
Requirements
- 10+ years in the pharmaceutical industry with proven leadership experience
- Deep quality expertise; experience with ophthalmic or large molecules is a plus
- Background in continuous improvement or analytics is helpful
- Strong project management, communication, and stakeholder skills
- Experience leading cross-functional teams to deliver on strategic initiatives
- Degree in a science, pharmacy, or engineering discipline; advanced degree welcome
- Track record of driving change and measurable improvements
- Commitment to professional growth and continuous learning
- Collaborative mindset and ability to build trust across diverse teams
- Willingness to travel 10-15% for assignments outside your primary location.
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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