Global Quality Operations Leader

PCI Pharma Services; Bedford (NH); On-site; USD 180,000 - 240,000; Full time

Job summary

PCI Pharma Services is seeking a senior Quality Operations Director to lead multi-shift teams and drive Right-First-Time manufacturing. You will own the QMS, oversee batch disposition tracking, and coordinate with partners and customers to ensure compliant, high-quality outcomes.

The role requires 5+ years in pharmaceutical GMP manufacturing, with strong leadership and regulatory knowledge. Budgeting, staffing, and staff development are key focus areas at PCI's Bedford site.

Qualifications

• Bachelor degree or equivalent relevant experience or certifications.
• Pharmaceutical manufacturing experience preferred.
• Past supervisory or managerial experience beneficial.
• Experience with contract manufacturing is a plus.
• Knowledge of CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10 and EU/Eudralex prioritized.

Responsibilities

• Lead quality operations across multiple shifts and coach shop floor teams to empower proactive decision-making.
• Monitor and improve PCI's QMS and related systems to maximize employee focus and Right-First-Time manufacturing.
• Maintain systems tracking batch disposition steps and partner data (QC data, EM results).
• Deliver predictable quality outcomes via continuous improvement, process controls, and data-driven decisions.
• Act as primary customer contact for quality operations and escalate with SDQO when needed.
• Ensure budgets are developed accurately and met, and manage staffing and training across shifts.

Education

Bachelor degree or equivalent

Job description

PCI Pharma Services is seeking a senior Quality Operations Director to lead multi-shift teams and drive Right-First-Time manufacturing. You will own the QMS, oversee batch disposition tracking, and coordinate with partners and customers to ensure compliant, high-quality outcomes.

The role requires 5+ years in pharmaceutical GMP manufacturing, with strong leadership and regulatory knowledge. Budgeting, staffing, and staff development are key focus areas at PCI's Bedford site.