Global Quality Operations Director

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford, Northern (NH, KY); Hybrid; USD 140,000 - 190,000; Full time

Job summary

PCI Pharma Services is seeking a QO Director to lead quality operations across multiple shifts in a GMP biopharma manufacturing environment. You will ensure Right-First-Time manufacturing, drive continuous improvement, and coach shop-floor teams to meet batch disposition requirements.

This role emphasizes strong regulatory knowledge, cross-functional collaboration with Operations, Maintenance, and Quality partners, and budget management to support production priorities while maintaining patient

Qualifications

• Approximately 5+ years’ experience in pharmaceutical/GMP manufacturing.
• Aseptic processing experience is highly preferred.
• Past experience as a supervisor or manager of employees is beneficial.
• Contract Manufacturing experience is a plus.
• Experience with global regulatory guidance (CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex) prioritized.

Responsibilities

• Lead the Quality Operations team across multiple shifts, driving compliance and consistency.
• Monitor and improve QMS, batch disposition, deviation management, and process controls.
• Coordinate training, staffing, and budget to meet production goals while ensuring patient safety.

Skills

pharma GMP

aseptic processing

supervisor experience

contract manufacturing

regulatory knowledge (CFR 210 211, 820

industrial management

Education

Bachelor degree or equivalent

Job description

PCI Pharma Services is seeking a QO Director to lead quality operations across multiple shifts in a GMP biopharma manufacturing environment. You will ensure Right-First-Time manufacturing, drive continuous improvement, and coach shop-floor teams to meet batch disposition requirements.

This role emphasizes strong regulatory knowledge, cross-functional collaboration with Operations, Maintenance, and Quality partners, and budget management to support production priorities while maintaining patient