Research & Development Quality Operations Specialty Lead
Core
Lead operational quality activities to protect patient safety and ensure reliable supply across manufacturing and supplier partners in the United States.
Role type
Senior Quality Operations Specialty Lead
Builds
Reliable supply of medicines and vaccines through validated GMP processes and supplier quality oversight
Domain
Biopharmaceutical manufacturing and supply chain
Required skills
GMP compliance, CAPA management, change control, batch record review, regulatory inspection preparation, root cause analysis, supplier quality oversight, risk assessment, data trending, aseptic formulation knowledge
Preferred skills
Contract manufacturer oversight, statistical methods, cross-functional leadership, continuous improvement, complex dosage form experience
Technologies
Robotics, digital solutions, artificial intelligence, smart manufacturing systems
Responsibilities
Develop and implement Quality R&D processes; approve GMP documentation and batch records; lead investigations and drive CAPA; manage audits and regulatory inspections; provide consultancy to reduce regulatory risk; coach suppliers and internal teams on quality compliance
Seniority
Senior, hands-on IC with leadership responsibilities