Manager, Quality Assurance

Lonza; Portsmouth (NH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Agile culture and dynamic working env.

Lead and develop a QA team

Exposure to complex biologics and QA/O

Collaborative cross-functional team

Performance-based compensation plans

Medical, dental, and vision insurance

Career growth and leadership programs

Job summary

Lonza is seeking a QA Operations Manager (Day Shift) in Portsmouth, NH to lead a high-performing QA team overseeing manufacturing quality, batch review, and product disposition readiness in a GMP setting.

The role partners with Manufacturing and Technical Operations to drive continuous improvement and ensure compliance, inspection readiness, and staff development in a fast-paced environment.

Qualifications

• 7+ years of Quality Assurance experience in a GMP-regulated biopharmaceutical/pharma environment.
• 3+ years of supervisory or management experience in QA.
• Strong knowledge of FDA/EMA/global GMP requirements including deviations, CAPAs, investigations, change controls, and product disposition processes.
• Proven leadership with ability to coach teams, manage priorities, and drive CI initiatives.

Responsibilities

• Lead daily QA Operations activities with quality oversight for manufacturing operations and regulatory compliance.
• Manage batch documentation review, product disposition readiness, and documentation quality for timely product release.
• Provide quality guidance and risk-based decision-making for manufacturing activities and quality events.
• Oversee deviations, investigations, CAPAs, change controls, risk assessments, and quality event management.
• Lead, coach, develop, and resource-plan QA Operations personnel fostering a collaborative, accountable team.
• Partner with Manufacturing, Supply Chain, Technical Operations, and Quality to identify risks and resolve issues.
• Drive operational excellence through metrics, standardization, and new systems/processes implementation.

Skills

QA leadership

GMP knowledge

Leadership

Communication

Problem-solving

Risk assessment

Cross-functional collaboration

Education

Bachelor's in Life Sciences

Advanced degree preferred

Job description

United States, Portsmouth (New Hampshire)

QA Operations Manager (Day Shift)

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 Operations Manager, you will lead a high-performing Quality Assurance team responsible for quality oversight of manufacturing operations, batch documentation review, and product disposition readiness in a fast-paced GMP manufacturing environment.

This role offers the opportunity to influence quality strategy, partner closely with Manufacturing and Technical Operations, and drive continuous improvement initiatives that support the delivery of life-changing therapies. You'll play a critical leadership role in ensuring compliance, operational excellence, and inspection readiness while developing and mentoring a team of quality professionals.

Shift: Day Shift

What you will get

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

What you will do

• Lead daily QA Operations activities, providing quality oversight and support for manufacturing operations while ensuring compliance with cGMP and regulatory requirements
• Manage batch documentation review activities, product disposition readiness, and documentation quality to support timely and compliant product release
• Provide quality guidance and risk-based decision-making for manufacturing activities, quality events, compliance issues, and operational challenges
• Oversee deviations, investigations, CAPAs, change controls, risk assessments, and quality event management to ensure timely resolution and sustainable compliance
• Lead, coach, develop, and resource-plan QA Operations personnel while fostering a collaborative, accountable, and performance-driven team environment
• Partner with Manufacturing, Supply Chain, Technical Operations, and Quality stakeholders to identify risks, resolve issues, and support operational success
• Drive operational excellence through performance metrics, continuous improvement initiatives, standardization efforts, and the implementation of new systems, tools, and processes

What we are looking for

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or a related discipline; advanced degree preferred
• Minimum 7 years of Quality Assurance experience within a GMP-regulated biopharmaceutical, pharmaceutical, or biotechnology environment
• Minimum 3 years of supervisory or management experience within a Quality organization
• Experience supporting manufacturing quality oversight, quality systems, operational quality management, and batch documentation review activities
• Strong knowledge of FDA, EMA, and global GMP requirements, including deviations, CAPAs, investigations, change controls, and product disposition processes
• Proven leadership experience with the ability to coach teams, manage priorities, and drive continuous improvement initiatives
• Strong communication, problem-solving, stakeholder management, and risk-based decision-making skills in a dynamic manufacturing environment

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.

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.