Global Quality Operations Director

PCI Pharma Services; Tennessee; On-site; USD 120,000 - 150,000; Full time

Job summary

PCI Pharma Services seeks a senior Quality Operations leader to oversee QO assets across shifts, driving compliant, Right-First-Time manufacturing. You will coach teams, manage budgets, and serve as the primary customer-facing quality contact.

A bachelor degree in life sciences or engineering and 5+ years in GMP pharma are required. Strong leadership, regulatory knowledge, and experience with aseptic operations are essential for success in this role at PCI.

Qualifications

• Bachelor degree or equivalent in life sciences, chemistry, engineering.
• Minimum 5 years in pharma/GMP manufacturing.
• Experience supervising or managing staff.
• Knowledge of CFR 210/211, 820, cGXP, ICH Q8–Q10, EU directives.
• Experience with production, aseptic operations, and validation.

Responsibilities

• Lead quality operations across multiple shifts and sites.
• Ensure compliance and investigate deviations.
• Coach shop floor teams and drive Right-First-Time manufacturing.
• Maintain budgets and staffing plans.
• Act as primary quality contact for customer communications.

Skills

Quality leadership

People management

Regulatory compliance

Problem solving

Education

Bachelor's degree in life sciences/engineering

Job description

PCI Pharma Services seeks a senior Quality Operations leader to oversee QO assets across shifts, driving compliant, Right-First-Time manufacturing. You will coach teams, manage budgets, and serve as the primary customer-facing quality contact.

A bachelor degree in life sciences or engineering and 5+ years in GMP pharma are required. Strong leadership, regulatory knowledge, and experience with aseptic operations are essential for success in this role at PCI.