Quality Director
Core
Directing site quality programs, systems, operations, and compliance activities to ensure manufactured and tested products meet registered quality specifications and regulatory requirements.
Role type
Senior Quality Director (Pharmaceutical Manufacturing)
Builds
Commercial and investigational pharmaceutical products
Domain
Pharmaceutical manufacturing / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality leadership, GMP compliance, regulatory inspection readiness, deviation investigation, budget management, strategic decision-making, cross-functional influence
Preferred skills
Master's degree in science or engineering, experience in complex matrix structures, coaching and staff development
Technologies
GMP Quality Systems, QMS Process Framework
Responsibilities
Direct all aspects of site quality programs and compliance activities; Ensure GMP Quality Systems are in place and inspection-ready; Align site procedures with BMS QMS; Investigate and resolve deviations; Interface with regulatory agencies and lead inspections; Participate in product recall processes; Manage departmental budget and spending; Oversee quality for regulatory submissions and new product introductions.
Seniority
Senior, hands-on IC with strategic leadership
