QC Strategy & Compliance Director (Senior)

PCI Pharma Services; England; On-site; GBP 150,000 - 200,000; Full time

Job summary

PCI Pharma Services in the United Kingdom is seeking a Senior Director, QC to provide strategic leadership of QC operations across the NH Development and Manufacturing campus, ensuring compliant, high-quality GMP testing and scalable laboratory capabilities.

You will drive method lifecycle management, capital expansion, and cross-functional collaboration with Manufacturing, MSAT, Validation, and QA to support growth, regulatory expectations, and client programs.

Qualifications

• BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field. Advanced level degree preferred
• 15+ years Pharmaceutical or Biotechnology industry experience
• Prior experience in leading a commercial, aseptic drug product quality control team
• 7+ years previous QC management experience
• Quality leadership experience with cross-functional teams to harmonize processes
• Prior CMOs experience preferred
• Excellent verbal, written, and interpersonal communication skills
• Ability to perform in a fast-paced environment
• Strong leadership to motivate and inspire teams
• Ability to mentor team members
• Management of 5+ direct reports across multiple sites with total group >50 people

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 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 cross-functionally with Manufacturing, MSAT, Validation, and QA to drive product quality
• Provide strategic oversight of method lifecycle management (development, transfer, validation)
• Ensure timely analytical support for formulation and process development
• Lead laboratory expansion and modernization initiatives (facility design, capacity, tech)
• Develop and manage departmental budgets, capex and resource planning
• Build, develop and retain high-performing leadership and technical teams
• Ensure QC operations remain inspection-ready with FDA/EMA/ICH compliance
• Support regulatory inspections and client audits as SME for QC
• Drive digitalization, automation and continuous improvement
• Provide oversight for supplier and contract lab quality governance
• Support regulatory submissions and health authority inquiries
• Monitor industry trends and emerging technologies to advance QC capabilities
• Perform other duties as assigned by executive leadership

Skills

Strategic leadership

QC management

Cross-functional collaboration

Regulatory readiness

Communication

Mentoring

Problem solving

Customer focus

Team development

Process improvement

Education

BS in life sciences (Chemistry/Biochemistry/Microbiology/Biology)

Job description

PCI Pharma Services in the United Kingdom is seeking a Senior Director, QC to provide strategic leadership of QC operations across the NH Development and Manufacturing campus, ensuring compliant, high-quality GMP testing and scalable laboratory capabilities.

You will drive method lifecycle management, capital expansion, and cross-functional collaboration with Manufacturing, MSAT, Validation, and QA to support growth, regulatory expectations, and client programs.