Director, Quality Assurance Operations
BioTalent Ltd, New York, NY, United States
We’re partnering with a rapidly scaling, global life sciences manufacturer investing heavily in quality, compliance, and operational excellence .
They’re hiring a Director, Quality Operations to lead and evolve site‑wide quality systems, drive performance, and build a best‑in‑class quality function.
The Role
Own and optimise the site Quality Management System (ISO 9001 / 13485 / cGMP)
Lead CAPA, non‑conformance, audit, and inspection frameworks
Oversee high‑risk investigations and product quality decisions
Drive continuous improvement across quality operations
Lead, mentor, and scale a high‑performing quality team
Partner cross‑functionally to ensure quality at scale across products and regions
What They Need
Proven leadership in pharma, biotech, or medical device manufacturing
Deep expertise in QMS, audits, CAPA, and regulatory compliance
Strong track record of driving quality transformation in scaling environments
Ability to influence at senior level and operate cross‑functionally
Why This Role
Senior leadership role with direct impact on global quality performance
Opportunity to shape and scale quality systems in a high‑growth environment
Visibility with executive leadership and influence over strategic direction
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They’re hiring a Director, Quality Operations to lead and evolve site‑wide quality systems, drive performance, and build a best‑in‑class quality function.
The Role
Own and optimise the site Quality Management System (ISO 9001 / 13485 / cGMP)
Lead CAPA, non‑conformance, audit, and inspection frameworks
Oversee high‑risk investigations and product quality decisions
Drive continuous improvement across quality operations
Lead, mentor, and scale a high‑performing quality team
Partner cross‑functionally to ensure quality at scale across products and regions
What They Need
Proven leadership in pharma, biotech, or medical device manufacturing
Deep expertise in QMS, audits, CAPA, and regulatory compliance
Strong track record of driving quality transformation in scaling environments
Ability to influence at senior level and operate cross‑functionally
Why This Role
Senior leadership role with direct impact on global quality performance
Opportunity to shape and scale quality systems in a high‑growth environment
Visibility with executive leadership and influence over strategic direction
#J-18808-Ljbffr