Director of Quality - Fairless Hills
1 day ago

Job description
Director of Quality - Sterile Injectables (QA & QC)Fairless Hills, PA
$180,000 - $230,000
Bonus Eligible (company performance based), 1st Shift, Full Site Quality Leadership
Are you ready to take full control of Quality across both QA and QC at a sterile injectables site entering production?
Looking for a position where you set the standard for the entire quality organization?
This is the senior-most Quality position on site, overseeing both Quality Assurance and Quality Control within a sterile injectables manufacturing environment transitioning into active production.
You will lead the full quality strategy - QA systems, laboratory operations, sterile compliance, inspection readiness, batch disposition, and overall quality culture.
This is a high-accountability role with executive visibility and direct impact on production success.
As the site moves fully into manufacturing, the expectation is clear: build strong systems, maintain regulatory confidence, and ensure sterile injectable operations meet the highest scientific and compliance standards.
You must be equally comfortable leading quality systems and laboratory functions, with the scientific credibility to guide both teams effectively.
If you have spent years leading sterile quality organizations and are ready for full-site ownership, this is a truly unique opportunity not to be missedThe Role:
Lead and oversee both QA and QC functions within a sterile injectables manufacturing site
Own quality systems, laboratory operations, compliance strategy, and inspection readiness
Provide executive-level quality leadership as production scales
Drive quality culture and ensure regulatory confidence across the organization
The Person:
Extensive leadership experience across both QA and QC in sterile injectables
Strong scientific background with credibility in aseptic manufacturing and sterile testing
Proven ability to operate as the senior Quality authority within a regulated environment
Reference Number:
#BBBH270165
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