Associate Director- Quality Control at a leading Global Pharma
Job description
Act as a quality leader responsible for ensuring high-quality, compliant analytical testing across global GxP laboratories (both internal and external). Oversee the full lifecycle of analytical activities, including method development, validation, release, and stability testing across multiple product types. Champion strong data integrity and quality systems in all laboratory work.
Review and approve key documentation, and lead or support laboratory-related investigations, audits, and inspections—driving effective corrective actions that directly impact patient safety and product quality. Partner closely with cross-functional teams, including R&D, regulatory, manufacturing, and quality, to support the analytical lifecycle and regulatory submissions (e.
g., IND, CTA, NDA, BLA).
Requirements
Provide quality oversight across GxP and non-GxP labs throughout the R&D lifecycle Review and approve key GMP/GLP documentation (methods, validations, deviations, CAPAs) Ensure strong ALCOA+ data integrity across systems, processes, and records Lead or support investigations, audits, and inspections with timely, effective CAPA Partner with cross-functional teams to align on quality standards and expectations