Global Quality Operations Director

pciservices; Bedford (NH); On-site; USD 110,000 - 150,000; Full time

Job summary

PCI is seeking a QO Director to lead Quality Operations across multiple shifts, ensuring GMP compliance and robust quality systems. You will guide asset leadership, coach shop-floor teams, and drive Right-First-Time manufacturing with a focus on patient safety.

The role includes maintaining batch disposition processes, managing budgets, and serving as the primary customer contact for quality issues. Experience in aseptic processing and regulated pharma is required.

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 working in a regulated industry with CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex

Responsibilities

• Lead Quality Operations across multiple shifts with focus on compliance.
• Coach shop floor teams and align decisions with quality objectives.
• Monitor and improve QMS and systems to maximize productivity and patient safety.
• Manage budgets and ensure batch disposition processes are traced and compliant.
• Serve as primary customer contact for quality-related escalations.

Skills

GMP

Aseptic processing

Supervision

Contract manufacturing

Regulatory knowledge

Job description

PCI is seeking a QO Director to lead Quality Operations across multiple shifts, ensuring GMP compliance and robust quality systems. You will guide asset leadership, coach shop-floor teams, and drive Right-First-Time manufacturing with a focus on patient safety.

The role includes maintaining batch disposition processes, managing budgets, and serving as the primary customer contact for quality issues. Experience in aseptic processing and regulated pharma is required.