Manager, Quality Assurance

Lonza • Portsmouth, NH

4d • Onsite

About The Position

As a QA Manager - Operations, you will lead a team at the heart of manufacturing quality, ensuring batch records are reviewed efficiently, compliance risks are assessed appropriately, and quality decisions support the successful delivery of life-changing therapies. This is a highly visible leadership opportunity for an experienced quality professional who excels at developing people, driving continuous improvement, and partnering cross-functionally to solve complex quality and compliance challenges. You will serve as a key quality leader across manufacturing operations, helping shape quality strategy while ensuring inspection readiness and operational excellence.

Requirements

• Bachelor's degree in a scientific discipline required
• 5-10 years of Quality Assurance experience in a GMP-regulated pharmaceutical, biotech, or life sciences environment
• Prior experience leading, mentoring, coaching, and developing direct reports
• Strong working knowledge of GMP regulations, quality systems, deviations, CAPAs, investigations, and change control processes
• Experience supporting regulatory inspections, customer audits, and quality compliance activities
• Excellent communication, decision-making, problem-solving, and stakeholder management skills with the ability to influence across all levels of the organization

Nice To Haves

• Experience with systems such as TrackWise, SAP, Syncade, and Microsoft Office applications preferred

Responsibilities

• Lead the QA Operations Batch Record Review team, providing daily oversight of batch record review activities and ensuring timely, compliant release support
• Recruit, train, coach, and develop QA Batch Record Reviewers while managing team workload, resource planning, and performance
• Provide guidance on quality and compliance observations, including severity assessments and determination of when quality records are required
• Partner with Manufacturing teams to review and resolve batch record and electronic batch record observations, ensuring accurate and compliant documentation
• Assess, review, and approve deviations, CAPAs, investigations, change controls, effectiveness checks, extensions, and other quality records in accordance with site procedures
• Serve as the primary Quality partner for Manufacturing Operations, supporting batch disposition activities, quality-related inquiries, and operational decision-making
• Represent Quality Assurance on cross-functional teams while driving continuous improvement initiatives, quality strategy development, inspection readiness, and Quality Management System effectiveness

Benefits

• An agile career and dynamic working culture
• Opportunities to lead, mentor, and develop a team of quality professionals
• Exposure to complex biologics manufacturing and quality operations
• A collaborative environment working closely with Manufacturing, QC, Engineering, MSAT, and Supply Chain teams
• Compensation programs that recognize high performance
• Medical, dental, and vision insurance
• Opportunities for career growth and leadership development

What This Job Offers

• Job Type: Full-time
• Career Level: Manager