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 pharmaceutical products (specifically flu vaccines) for patient delivery
Domain
Pharmaceutical manufacturing / Biotechnology / Regulatory Compliance
Required skills
Quality assurance leadership, CMC regulatory guidance application, risk-based decision making, cross-functional integration, regulatory filing review, Lean process improvement, team mentorship
Preferred skills
QP eligibility, egg-based flu manufacturing expertise, advanced degree, method/process development experience
Technologies
Lean methodologies, digital models, regulatory databases
Responsibilities
Represent Quality on global teams, drive information flow to CMC and site leads, act as a bridge between development and operations, implement CMC strategies, maintain quality understanding from cell banking to post-release, provide data-driven risk advice, review regulatory filings, lead the Quality Product Team, contribute to global standards, identify continuous improvement opportunities, mentor colleagues
Seniority
Director, strategic leadership & team management