Director of Quality

We are currently supporting a pharmacy organization building its first 503B outsourcing facility in Virginia that is looking to hire a Director of Quality.

This is a foundational, greenfield leadership hire. The organization is seeking a Director-level Quality leader to architect, implement, and own the Quality function during facility build-out and pre-commercial operations.

The priority is heavily weighted toward Quality Assurance. This individual must be a true QA leader first and foremost who is capable of building, strengthening, and owning the Quality Management System from the ground up. In addition, the ideal profile will bring working knowledge of Quality Control and be capable of overseeing QC strategy, laboratory oversight, and method governance, even if day-to-day QC execution is supported by SMEs or future hires.

This is not a maintenance role within an established system. This is a build-from-scratch quality leadership engagement within a regulated 503B environment.

• Build and implement the Quality Management System (QMS) for a new 503B outsourcing facility
• Establish and maintain compliance under FDA cGMP standards
• Lead FDA inspection readiness strategy from startup phase through commercialization
• Own deviation management, CAPA, change control, risk management, and documentation systems
• Provide QA oversight of validation, CQV activities, and facility qualification
• Oversee QC framework, laboratory governance, and analytical compliance strategy
• Support development and approval of SOPs, quality policies, and procedural controls
• Partner closely with Engineering and Manufacturing during startup implementation
• Serve as the primary quality authority during early facility build and operational readiness

• Director-level Quality leadership experience in FDA-regulated manufacturing
• Strong Quality Assurance background with demonstrated QMS ownership
• Working knowledge of Quality Control oversight and analytical governance
• Deep experience with FDA inspection readiness and cGMP compliance
• Experience with in sterile or injectable manufacturing environments
• Ability to operate within a startup, build-phase environment
• Willingness to maintain regular onsite presence in Chantilly, VA

• Prior 503B outsourcing facility experience
• Experience leading or supporting FDA inspections within sterile compounding environments
• Experience supporting validation strategy and startup facility build-out
• Exposure to nutraceutical injectables, hormone pellet manufacturing, or similar sterile products

This is a high-visibility opportunity to build and lead the Quality function of a new 503B facility from inception through commercial readiness.

Please do not contact if you are a third party vendor.