Manager, Quality Assurance

Lonza; Portsmouth (NH); Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

Career growth opportunities

Leadership development

Collaborative cross-functional culture

Competitive compensation

Zusammenfassung

Lonza in Portsmouth, NH is seeking a QA Manager - Operations to lead a high-performing batch record review team and ensure compliant release of biologics manufacturing outputs. You will drive quality decisions, risk assessments, and cross-functional collaboration to support on-time delivery of therapies.

You will mentor QA staff, partner with Manufacturing, QC, and MSAT, and shape quality strategy while maintaining inspection readiness and continuous improvement across the site.

Qualifikationen

• Bachelor’s degree in a scientific discipline required.
• 5–10 years QA experience in GMP-regulated environment.
• Experience leading and developing staff and cross-functional partners.

Aufgaben

• Lead QA Operations Batch Record Review and release support.
• Mentor and develop QA reviewers and manage workload.
• Provide guidance on deviations, CAPAs, investigations, and change controls.
• Collaborate with Manufacturing to resolve observations and ensure compliant docs.
• Support batch disposition and regulatory inspections readiness.
• Drive continuous improvement and QA strategy across operations.

Kenntnisse

QA Leadership

GMP Knowledge

Stakeholder Management

Decision Making

Analytical Thinking

Ausbildung

Bachelor’s degree in a scientific discipline

Tools

TrackWise

SAP

Syncade

MS Office

Jobbeschreibung

QA Manager - Operations

Location: Portsmouth, NH (On-site)

At Lonza, our greatest scientific solution is talented people working together to help improve lives around the world. 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.

What you will get

• 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 you will do

• 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

What we are looking for

• 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
• Experience with systems such as TrackWise, SAP, Syncade, and Microsoft Office applications preferred
• Excellent communication, decision-making, problem-solving, and stakeholder management skills with the ability to influence across all levels of the organization

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.