Director Product Quality
Core
Lead the strategy and execution of quality across the full product lifecycle for a high-profile flu franchise, ensuring reliability and speed to patients.
Role type
Director, Product Quality (Pharmaceutical Manufacturing)
Builds
Robust product plans, regulatory filings, and reliable medicine supply for the Flu Franchise.
Domain
Pharmaceutical manufacturing (Flu vaccines), CMC, Regulatory Compliance
Required skills
Quality assurance leadership, CMC regulatory guidance application, risk-based decision making, cross-functional integration, global regulatory body interaction, Lean process improvement
Preferred skills
Post-graduate qualification, method/process development experience, QP eligibility, egg-based flu manufacturing knowledge
Technologies
Lean methodologies, digital models, regulatory filing systems
Responsibilities
Represent Quality on global teams as the liaison for the Flu Franchise; drive information flow to CMC and Quality Product Teams; act as a communication bridge between development, CMC, Quality, and Operations; review and approve regulatory filings; lead the Quality Product Team to resolve challenges; contribute to global standards and development procedures; mentor colleagues across the Quality team.
Seniority
Director, strategic leadership & cross-functional influence