QA Manager, Operations — GMP Compliance & CI Leader

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Job summary

Lonza is seeking a Quality Assurance Manager, Operations in Portsmouth, NH. You will lead a QA team ensuring GMP compliance across site operations, collaborating with Manufacturing, MSAT, Engineering, QC, Validation, and Supply Chain to resolve complex quality issues.

The role emphasizes continuous improvement and quality metrics oversight via Change Control and CAPA processes. The ideal candidate has extensive QA leadership experience in regulated manufacturing, excellent communication, and the

Qualifications

• 5–10 years of quality assurance experience in biotech/pharma or regulated manufacturing.
• Experience leading QA teams, coaching, and talent development.
• Strong knowledge of GMP regulations and quality systems.

Responsibilities

• Lead a team of QA Compliance Specialists and QA Project Managers to deliver quality objectives.
• Provide guidance and escalation for quality issues affecting stakeholders.
• Ensure alignment with regulatory requirements and internal SOPs across QA activities.
• Collaborate with Manufacturing, MSAT, Engineering, QC, Validation, and Supply Chain to resolve quality issues.
• Participate in Change Control, Deviations Review Board, CAPA Board, and Site Quality Council.
• Oversee quality metrics, deviation trending, and performance indicators to drive continuous improvement.
• Perform and support lot release and disposition activities per GMP standards.
• Drive initiatives to enhance quality systems and site-wide compliance.

Skills

GMP knowledge

Leadership/people mgmt

Cross-functional collaboration

Regulatory compliance

Quality systems

Analytical skills

Tools

TrackWise

SAP

Syncade

Microsoft Office

Job description

Lonza is seeking a Quality Assurance Manager, Operations in Portsmouth, NH. You will lead a QA team ensuring GMP compliance across site operations, collaborating with Manufacturing, MSAT, Engineering, QC, Validation, and Supply Chain to resolve complex quality issues.

The role emphasizes continuous improvement and quality metrics oversight via Change Control and CAPA processes. The ideal candidate has extensive QA leadership experience in regulated manufacturing, excellent communication, and the