Global Quality Executive Director, Life Sciences

pciservices; Bedford (NH); On-site; USD 180,000 - 230,000; Full time

Job summary

PCI is seeking an Executive Director, Quality for the Development & Manufacturing Bedford campus. You will provide strategic and operational leadership for QA, QC, Validation, and the Quality Management System, ensuring regulatory compliance and patient safety.

As a member of the Site Leadership Team, you will balance quality with production, safety, and financial priorities while developing a high‑performing quality organization and driving long‑term strategy and capability expansion.

Qualifications

• 15+ years in a similar pharma/biopharma org with senior management experience.
• Strong knowledge of CFR 210/211, 820, cGXP, ICH Q8-10, EU/Eudralex.
• Experience in aseptic or sterile production and contract manufacturing is a plus.

Responsibilities

• Develop and communicate a strategic quality vision to be a competitive advantage.
• Ensure QMS and systems enable Right-First-Time manufacturing and inspection readiness.
• Lead QA, QC, and Validation across the Bedford D&M campus with site leadership.
• Balance worker safety, quality, finance, and production while meeting customer needs.
• Manage regulatory inspections and interactions with regulatory agencies.
• Develop and manage the annual Quality budget and long-term resource planning.

Skills

Executive leadership

Quality management

Regulatory compliance

cGMP knowledge

Job description

PCI is seeking an Executive Director, Quality for the Development & Manufacturing Bedford campus. You will provide strategic and operational leadership for QA, QC, Validation, and the Quality Management System, ensuring regulatory compliance and patient safety.

As a member of the Site Leadership Team, you will balance quality with production, safety, and financial priorities while developing a high‑performing quality organization and driving long‑term strategy and capability expansion.