Quality Compliance Project Manager

Quality Compliance Project Manager

Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 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 will you do:

We are seeking a Quality Compliance Project Manager to support the successful execution of customer programs and quality initiatives within a cGMP manufacturing environment. This role serves as the primary quality liaison for assigned customers, ensuring compliance, proactive communication, and timely execution of quality deliverables throughout the product lifecycle. The ideal candidate will combine strong quality systems knowledge with project management expertise and customer-facing experience.

• Serve as the primary Quality Assurance representative and point of contact for assigned customer programs, building strong internal and external relationships

• Act as the quality lead for product lifecycle activities, including technology transfers, new product introductions, process improvements, and product discontinuation projects

• Chair Joint Quality Team meetings, establish agendas, document meeting outcomes, and track actions to completion

• Partner with cross-functional teams to ensure quality-related deliverables, milestones, and commitments are executed on time and in compliance with regulatory requirements

• Assess quality records, including deviations, change controls, CAPAs, and vendor notifications, to determine customer impact and appropriate communication requirements

• Manage customer quality communications, including notification processes, review cycles, responses to customer feedback, and approval activities

• Develop, maintain, and revise Quality Agreements, ensuring responsibilities and commitments are clearly defined and executed

• Support batch disposition activities, quality documentation review and approval, customer reporting, KPI generation, and continuous improvement initiatives as required

What we are looking for:

• Bachelor’s degree in microbiology, Biochemistry, Life Sciences, or a related scientific field; equivalent experience may be considered

• 5–10 years of experience in a pharmaceutical, biotechnology, cell and gene therapy, or other cGMP-regulated environment

• Strong knowledge of GMP regulations, quality systems, and product lifecycle management processes

• Experience managing complex projects, cross-functional initiatives, and competing priorities within a regulated environment

• Demonstrated ability to build strong relationships with customers and internal stakeholders while effectively managing expectations

• Experience with quality systems, including deviations, CAPAs, change controls, investigations, and Quality Agreements

• Strong communication, facilitation, and presentation skills, with the ability to represent Quality Assurance in customer and leadership meetings

• Excellent organizational, analytical, and problem-solving skills, with the ability to make sound, risk-based decisions and drive projects to completion

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? Apply now.