Senior Director, Global QC Strategy & Lab Excellence

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 180,000 - 250,000; Full time

Job summary

PCI Pharma Services seeks a Senior Director of Quality Control to lead QC operations at our NH Development and Manufacturing campus. You will direct cGMP testing, strategy, and lab modernization while ensuring regulatory readiness and robust CAPA programs.

You will partner with cross-functional teams to support client programs, manage budgets, and mentor a large QC organization across sites. A strong regulatory mindset and leadership presence are essential.

Qualifications

• BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field.
• Advanced degree preferred.
• 15+ years Pharmaceutical or Biotechnology industry experience.
• Leading a commercial, aseptic drug product quality control team.
• 7+ years previous QC management experience.
• Quality leadership experience with cross-functional teams.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• CMO experience preferred.
• Mentoring and developing teams encouraged.
• Direct reports 5+ across multiple sites with 50+ total.

Responsibilities

• Provide strategic and operational leadership for all Quality Control functions, ensuring compliant cGMP testing.
• Establish and drive QC vision, strategy, and long-term roadmap.
• Oversee investigations (deviations, OOS/OOT) and CAPA across labs.
• Serve as client interface for QC and program governance.
• Build client relationships and identify opportunities to expand services.
• Partner with Manufacturing, MSAT, Validation, QA for end-to-end quality.
• Oversee method lifecycle management and continuous improvement.
• Ensure analytical support for formulation and process development programs.
• Lead lab expansion, capacity planning, and tech implementation.
• Manage budgets, capital investments, and resources.

Skills

Leadership

Cross-functional

Strategic thinking

Regulatory knowledge

Communication

Problem solving

Education

BS in Chemistry/Biochemistry/Microbiology/Biology

Advanced degree preferred

15+ years pharma/biotech experience

QC leadership in aseptic drug products

7+ years QC management

CMO/outsourcing experience

Job description

PCI Pharma Services seeks a Senior Director of Quality Control to lead QC operations at our NH Development and Manufacturing campus. You will direct cGMP testing, strategy, and lab modernization while ensuring regulatory readiness and robust CAPA programs.

You will partner with cross-functional teams to support client programs, manage budgets, and mentor a large QC organization across sites. A strong regulatory mindset and leadership presence are essential.