Quality Assurance Manager, Operations

Lonza Biologics, Inc.; Portsmouth (VA); On-site; Confidential; Full time

Job summary

Lonza Biologics, Inc. is seeking an experienced Quality Assurance Manager, Operations to lead a high-performing QA team and ensure GMP compliance across site operations in the Portsmouth, NH area.

The role emphasizes quality oversight, process improvements, and strong collaboration with Manufacturing, MSAT, Engineering, QC, and Supply Chain. The ideal candidate has 5–10 years in QA within regulated biopharma manufacturing, proven leadership, and a track record of addressing complex quality

Qualifications

• 5-10 years of experience in quality assurance within biotechnology/pharmaceutical manufacturing
• Strong knowledge of GMP regulations, quality systems, and compliance requirements
• Experience supporting investigations, deviations, CAPA, and change control processes

Responsibilities

• Lead and manage a team of QA Compliance Specialists and QA Project Managers, ensuring timely and effective delivery of quality objectives
• Provide guidance and act as a point of escalation for quality-related issues impacting internal and external stakeholders
• Ensure alignment with regulatory requirements, customer Quality Agreements, and internal SOPs across all QA activities
• Partner cross-functionally with Manufacturing, MSAT, Engineering, QC, Validation, and Supply Chain to resolve complex quality issues
• Support and participate in key quality forums, including Change Control, Deviations Review Board, CAPA Board, and Site Quality Council
• Oversee and track quality metrics, including deviation trending and performance indicators, to support continuous improvement
• Perform and support lot release and disposition activities in accordance with GMP standards
• Drive continuous improvement initiatives to enhance quality systems, processes, and overall site compliance

Skills

Leadership

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Analytical skills

Tools

TrackWise

SAP

Syncade

Microsoft Office

Job description

Quality Assurance Manager, Operations

Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM-4:30 PM EST.

What you will get:

Below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.

• Medical, dental and vision insurance.

• 401(k) matching plan.

• Life insurance, as well as short-term and long-term disability insurance.

• Employee assistance programs.

• Paid time off (PTO).

Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.

What you will do:

We are seeking an experienced Quality Assurance Manager, Operations to lead a team supporting GMP compliance and quality oversight across site operations. This role is responsible for ensuring quality objectives are achieved, supporting cross-functional teams, and promoting a strong culture of quality and continuous improvement. The ideal candidate will bring leadership experience within a regulated manufacturing environment and the ability to effectively manage priorities, people, and processes.

• Lead and manage a team of QA Compliance Specialists and QA Project Managers, ensuring timely and effective delivery of quality objectives

• Provide guidance and act as a point of escalation for quality-related issues impacting internal and external stakeholders

• Ensure alignment with regulatory requirements, customer Quality Agreements, and internal SOPs across all QA activities

• Partner cross-functionally with Manufacturing, MSAT, Engineering, QC, Validation, and Supply Chain to resolve complex quality issues

• Support and participate in key quality forums, including Change Control, Deviations Review Board, CAPA Board, and Site Quality Council

• Oversee and track quality metrics, including deviation trending and performance indicators, to support continuous improvement

• Perform and support lot release and disposition activities in accordance with GMP standards

• Drive continuous improvement initiatives to enhance quality systems, processes, and overall site compliance

What we are looking for:

• 5-10 years of experience in quality assurance within a biotechnology, pharmaceutical, or regulated manufacturing environment

• Proven experience managing and developing teams, including coaching, performance management, and talent development

• Strong knowledge of GMP regulations, quality systems, and compliance requirements

• Experience supporting or leading investigations, deviations, CAPA, and change control processes

• Ability to effectively collaborate with cross-functional teams and influence decision-making in a matrixed environment

• Strong organizational and analytical skills, with the ability to manage multiple priorities and meet deadlines

• Excellent communication skills, with the ability to engage effectively across all levels of the organization

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

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.

Ready to shape the future of life sciences?