Our client is a well-established, industry-leading manufacturer of sterile injectable pharmaceutical products, with a multi-decade track record supplying healthcare providers and veterinarians across the United States and Canada. The organization is recognized as a top-10 injectable manufacturer and has built its reputation on reliability and consistency of supply in a sector where drug shortages are a constant industry challenge.
The company differentiates itself through deep expertise in complex, hard-to-manufacture sterile injectables — including small molecule, cytotoxic large molecule, and pre-filled syringe (PFS) and combination products — and through sustained, multi-site U.S.-based manufacturing investment that keeps its supply chain short and dependable.
“When the industry can’t supply it, this is the company hospitals call - and their quality organization is the reason the answer is always yes.” — Industry trade publication
The Role They Will Play
This is quality leadership at the intersection of patient safety and operational excellence — owning the standards that keep sterile injectables flowing to the people who depend on them, with zero room for compromise.
The Quality Affairs Sr. Director will own quality management across deviations, CAPA, change control, document control, annual product review, technical services, and external client oversight, while also holding direct responsibility for site quality control functions - stability, chemistry, microbiology, and environmental/particulate monitoring.
Unlike a lab-focused QA role, this position carries full accountability across both quality control and manufacturing quality operations - a broader mandate than the position it succeeds, with correspondingly higher visibility to regulatory agencies and site leadership.
For the right leader, this is a running start toward site-wide quality executive responsibility, with a company actively investing in capital expansion and new product platforms.
This role calls for a seasoned quality executive who has led both quality control and manufacturing quality operations at scale within sterile injectable pharmaceutical manufacturing, and who is ready to take on multi-site oversight during a period of active capital expansion. Ideal candidates will bring:
- Expertise in cGMP compliance for sterile injectable pharmaceutical manufacturing and laboratory operations.
- 15+ years’ progressive experience in pharmaceutical operations and interactions with regulatory agencies.
- Exposure to regulatory body inspection management (e.g., FDA, EMEA, Health Canada).
- Working Knowledge of validation for pharmaceutical manufacturing facility expansion, tech transfer, and new product launches.