Global Quality Operations Leader

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

PCI Pharma Services seeks a senior Quality Operations leader to oversee multiple units, ensuring GMP compliance, flow of information, and batch disposition accuracy. You'll coach a diverse team, manage budgets, and drive continuous improvement across production and quality systems.

The role requires strong regulatory knowledge, cross-functional collaboration, and a track record of improving Right-First-Time manufacturing outcomes in a complex biotech/pharma setting.

Qualifications

• Minimum 5+ years in pharmaceutical / GMP manufacturing.
• Supervisory/managerial experience of employees is beneficial.
• Experience with regulated industry and global regulatory guidance (e.g., CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex).

Responsibilities

• Lead multiple unit Quality Operations teams to ensure Right-First-Time manufacturing.
• Manage budgets, staffing, and training to maintain compliance and performance.
• Coach shop floor personnel and maintain clear line-of-sight to batch disposition and deviations.
• Ensure QMS and related systems are effective and continuously improved.

Skills

Quality leadership

GMP knowledge

Regulatory knowledge

Supervisory experience

Budgeting experience

Communication

Cross-functional collaboration

Education

Bachelor's degree or higher

Tools

QMS

GEMBA

Job description

PCI Pharma Services seeks a senior Quality Operations leader to oversee multiple units, ensuring GMP compliance, flow of information, and batch disposition accuracy. You'll coach a diverse team, manage budgets, and drive continuous improvement across production and quality systems.

The role requires strong regulatory knowledge, cross-functional collaboration, and a track record of improving Right-First-Time manufacturing outcomes in a complex biotech/pharma setting.