Director, Quality
Core
Senior Quality Assurance leadership responsible for global quality strategy, site culture of safety and compliance, and oversight of QA/regulatory functions for biologics and oral solid dosage forms.
Role type
Senior Quality Assurance Director (Site & Global Leadership)
Builds
Integrated analytical and manufacturing services for biologics and oral solid dosage forms
Domain
Pharmaceutical manufacturing / Biologics / cGMP
Deliverable
infrastructure
Required skills
cGMP regulations, validation principles (processes/equipment/methods), quality system implementation, strategic planning, people management, regulatory agency interaction, internal investigations
Preferred skills
Leadership program experience (NGGL, GOLD, LEAD Now)
Technologies
GMP documentation systems, validation protocols
Responsibilities
Create and implement Business Unit quality strategy and global quality policies; Lead development of site Quality Objectives, Quality Plans, and Quality Management Reviews; Oversee Performance Management Program actions including appraisals and talent development; Conduct internal investigations on cGMP issues and customer complaints; Review and approve GMP documentation including SOPs and batch records; Coordinate customer and Regulatory Audits
Seniority
Senior, hands-on IC with strategic scope