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
Director, Quality Assurance – Value Chain Management
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