Quality Executive Director, Global Compliance & Innovation

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 180,000 - 230,000; Full time

Job summary

PCI Pharma Services in Bedford, NH, seeks an Executive Director, Quality to lead QA, QC, and Validation across Development and Manufacturing. You will shape the Quality Management System, ensure regulatory compliance, and drive Right-First-Time manufacturing while partnering with the Site GM and SLT.

The role requires significant senior leadership experience in aseptic production, a strong regulatory background, and a strategic, operations-focused mindset.

Qualifications

• 15+ years in a similar organization with 5+ years in a senior management role
• Aseptic or sterile production experience is preferred
• Regulatory knowledge incl CFR 210/211, 820, cGXP, ICH Q8/9/10, EU/Eudralex
• Experience implementing and maintaining total quality systems and driving metrics

Responsibilities

• Develop and implement a clear Quality strategy to gain competitive advantage
• Maintain and improve QMS systems to enable Right-First-Time manufacturing
• Ensure inspection readiness and regulatory compliance across D&M campus
• Lead QA, QC, & Validation with a focus on personnel development and budget
• Interface with Regulatory Agencies and manage inspections
• Develop quality budgets and align with site leadership objectives

Skills

Quality leadership

Regulatory compliance

cGMP knowledge

People management

Quality systems

QA/QC/Validation

Education

Bachelor's degree in life sciences/engineering

Advanced degree desirable

Tools

eQMS

Process mapping tools

Data analysis tools

Job description

PCI Pharma Services in Bedford, NH, seeks an Executive Director, Quality to lead QA, QC, and Validation across Development and Manufacturing. You will shape the Quality Management System, ensure regulatory compliance, and drive Right-First-Time manufacturing while partnering with the Site GM and SLT.

The role requires significant senior leadership experience in aseptic production, a strong regulatory background, and a strategic, operations-focused mindset.