Senior Director, QC Strategy & Global Operations

PCI Pharma Services; Bedford (NH); On-site; USD 190,000 - 270,000; Full time

Job summary

PCI Pharma Services in New Hampshire seeks a Senior Director, Quality Control to lead and shape QC operations across the development and manufacturing campus, driving cGMP testing, regulatory readiness, and scalable laboratory capabilities to support client programs.

The role partners with Manufacturing, MSAT, Validation, and QA to deliver high-quality testing, oversee method lifecycle management, budget planning, and expansion initiatives, while building a high-performing, compliant team.

Qualifications

• BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field; advanced degree preferred.
• 15+ years Pharmaceutical or Biotechnology industry experience.
• Experience leading a commercial, aseptic drug product quality control team.
• 7+ years QC management experience.
• Strong leadership to harmonize operations and compliance across functions.
• CMO experience preferred.
• Excellent verbal and written communication in a fast-paced environment.
• Mentor and lead 5+ direct reports across multiple sites.

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 aligned with growth and regulatory expectations.
• 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.
• Lead laboratory expansion, capital planning, capacity modeling, and technology implementation.
• Ensure QC operations remain inspection-ready with FDA/EMA/ICH compliance.
• Support regulatory inspections and client audits; act as subject matter expert for QC.
• Drive digitalization, automation, and continuous improvement to enhance efficiency and data integrity.

Skills

Quality Leadership

Cross-functional Leadership

Client interface

Regulatory compliance

People management

Education

BS in Chemistry/Biochemistry/Microbiology/Biology

Job description

PCI Pharma Services in New Hampshire seeks a Senior Director, Quality Control to lead and shape QC operations across the development and manufacturing campus, driving cGMP testing, regulatory readiness, and scalable laboratory capabilities to support client programs.

The role partners with Manufacturing, MSAT, Validation, and QA to deliver high-quality testing, oversee method lifecycle management, budget planning, and expansion initiatives, while building a high-performing, compliant team.