Senior Director, QC: Strategy, Compliance & Lab Modernization

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 180,000 - 240,000; Full time

Job summary

PCI Pharma Services seeks a Senior Director, QC to provide strategic leadership across the NH Development and Manufacturing campus. You will drive cGMP testing, regulatory readiness, and client‑facing programs while shaping the QC roadmap and capital plans.

You will lead investigations, CAPA, and cross‑functional teams to ensure data integrity and robust quality across materials, in‑process, release, and stability testing, supporting growth and regulatory expectations.

Qualifications

• BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field.
• Advanced level degree preferred.
• 15+ years Pharmaceutical or Biotechnology industry experience.
• 7+ years previous QC management experience, with cross-functional leadership.

Responsibilities

• Provide strategic and operational leadership for all Quality Control functions, ensuring compliant execution of cGMP testing.
• Establish and drive QC vision, strategy, and long-term roadmap.
• Oversee investigations (deviations, OOS/OOT, EM excursions) with robust root cause analysis and CAPA.
• Serve as client interface for QC, supporting business development and program governance.
• Build and maintain strong client relationships and identify opportunities to expand services.
• Partner with Manufacturing, MSAT, Validation, and QA to drive end-to-end product quality and process performance.
• Oversee method lifecycle management (development, transfer, validation, continuous improvement).
• Ensure analytical support for formulation and process development programs.
• Lead laboratory expansion and modernization initiatives including facility design and capacity planning.

Skills

Leadership

QC Leadership

Regulatory Knowledge

Cross-functional

Education

BS in life sciences

Job description

PCI Pharma Services seeks a Senior Director, QC to provide strategic leadership across the NH Development and Manufacturing campus. You will drive cGMP testing, regulatory readiness, and client‑facing programs while shaping the QC roadmap and capital plans.

You will lead investigations, CAPA, and cross‑functional teams to ensure data integrity and robust quality across materials, in‑process, release, and stability testing, supporting growth and regulatory expectations.