Executive Director, Quality
PCI Pharma Services · Usa_nh_bedford_23com
QualityFull-timeCompany career page
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Role summary
PCI Pharma Services seeks an Executive Director of Quality to lead strategic and operational oversight of quality, assurance, control, and validation functions at its Bedford manufacturing campus. The role balances regulatory compliance, patient safety, and operational excellence while serving as a senior leadership team member.
What they're looking for
- 15+ years in similar organization; at least 5 years in senior management role
- Majority of experience in aseptic or sterile production environments
- Deep knowledge of CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex Annex 1
- Demonstrated track record implementing and maintaining total quality management systems
- Strong foundation in production, aseptic operations, microbiology, analytical chemistry, validation
- Experience managing regulatory inspections and communicating with global regulatory agencies
- Bachelor's degree minimum
What you'll be doing
- Develop and communicate strategic quality vision positioning quality as competitive advantage
- Ensure quality management systems and processes enable right-first-time manufacturing
- Maintain constant inspection readiness and regulatory compliance for stable patient supply
- Lead quality teams across QA, QC, and validation; manage personnel development and succession planning
- Oversee compliance operations including investigations, audits, batch disposition, and product trending
Privacy & handoff
This role links to PCI Pharma Services's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.