Senior Quality Operations Leader, GMP & Compliance

Jobtailor; Bedford (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

PCI is seeking a functional quality leader to drive quality operations across multiple business units in Bedford, NH. You will balance worker safety, environmental compliance, finance, production, supply, and customer needs while guiding the Quality Operations Asset Leadership Team on the shop floor.

You will oversee QMS and regulatory systems, coach frontline teams, ensure training and competency, manage budgets, and serve as the customer-facing Quality organization.

Qualifications

• 5+ years’ experience in pharmaceutical / GMP manufacturing.
• Aseptic processing experience highly preferred.
• Experience managing a team across multiple shifts.
• Knowledge of CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex.
• Minimum Bachelor degree or equivalent experience.

Responsibilities

• Serve as the functional quality leader for multiple business units.
• Balance worker safety, quality, environmental compliance, and customer needs.
• Lead the Quality Operations Asset Leadership Team and coach shop floor teams.
• Oversee QMS and other systems to maximize Right-First-Time manufacturing.
• Provide feedback to QMS owners to improve performance.
• Maintain visibility into batch disposition requirements and final disposition steps.
• Deliver predictable quality outcomes through continuous improvement and controls.
• Schedule, assign, monitor, and trend GEMBAs and process observations.
• Manage Quality professionals across shifts and drive compliance.
• Foster collaboration and share best practices among frontline personnel.
• Empower the team to make sound shop floor decisions with review.
• Serve as the customer-facing Quality organization and primary contact for communications.
• Act as a visible leader and example of PCI’s Industrial Quality Mindset.
• Develop staff, strengthen process knowledge, and ensure succession planning.
• Develop and meet budgets.

Skills

Quality Management Systems (QMS)

Pharmaceutical Manufacturing

Regulatory Compliance CFR 210 211 820

Aseptic Processing

Industrial Management Skills

GEMBA Observations

Budget Management

Staffing Management

Training and Competency Development

Quality Mindset

Education

Bachelor Degree or Equivalent Experience

Tools

GEMBA Observations

Validation

Job description

PCI is seeking a functional quality leader to drive quality operations across multiple business units in Bedford, NH. You will balance worker safety, environmental compliance, finance, production, supply, and customer needs while guiding the Quality Operations Asset Leadership Team on the shop floor.

You will oversee QMS and regulatory systems, coach frontline teams, ensure training and competency, manage budgets, and serve as the customer-facing Quality organization.