Executive Director, Quality & Compliance

PCI Pharma Services; Bedford (NH); On-site; USD 220,000 - 300,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks an Executive Director of Quality to lead QA, QC, Validation and the Quality Management System, ensuring cGMP compliance, inspection readiness and patient safety.

You will partner with the Site GM and SLT to set long-term quality strategy, develop talent, invest in systems, and deliver Right-First-Time manufacturing while balancing safety, production and regulatory requirements.

Qualifications

• 15+ years in a similar organization with five+ years in a senior management role in aseptic production
• Strong knowledge of CFR 210/211, 820, ICH Q8–Q10, EU/Eudralex regulations
• Demonstrated track record implementing and leading total quality systems and strategic quality plans
• Experience in facilitating regulatory inspections and communicating with global regulatory agencies
• Hands-on experience with QMS data management software (eQMS) and risk assessments
• Cross-functional leadership across multiple stakeholders to meet diverse priorities
• Bachelor’s degree; life sciences/engineering preferred; advanced degree desirable

Responsibilities

• Develop and communicate a strategic quality vision as a competitive advantage
• Ensure QMS readiness and regulatory compliance across the site
• Maintain inspection readiness and anticipate regulatory changes
• Partner with Site GM to balance safety, quality, production and cost
• Lead QA, QC and Validation across the Bedford D&M campus
• Model senior leadership behaviors within the SLT
• Oversee quality aspects of manufacturing, testing, packaging and release
• Align site quality planning with corporate requirements and budgets
• Ensure regulatory inspections are managed and documented
• Negotiate quality agreements with clients and suppliers
• Develop and manage the annual quality budget

Skills

Quality management

Regulatory compliance

cGMP knowledge

Leadership

Quality systems

Education

Bachelor’s degree

Advanced degree desirable

Tools

eQMS

Process mapping

Risk assessments

Data analysis

Presentation tools

Job description

PCI Pharma Services in Bedford, NH seeks an Executive Director of Quality to lead QA, QC, Validation and the Quality Management System, ensuring cGMP compliance, inspection readiness and patient safety.

You will partner with the Site GM and SLT to set long-term quality strategy, develop talent, invest in systems, and deliver Right-First-Time manufacturing while balancing safety, production and regulatory requirements.