QA Compliance Manager

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Quality Assurance (QA) Compliance Manager leads a team of QA Compliance Specialists and QA Project Managers that are responsible for supporting Lonza's internal and external customers with deviation, CAPA, and change control management; review and revision of customer quality agreements; and preparation, review and approval or Product Quality Report (PQR) sections relating to quality.  The Manager ensures staff is meeting objectives and deliverables on time and in-full, performs key functions such as lot release and co-chairing the Deviation Review Board and/or CAPA (Corrective and Preventative Action) Review Board and supports the overflow of tasks as needed to ensure deliverables are met.  The Manager assigns the resources and priorities, ensures adequate training, coaches and develops employees and evaluates performance, actively pursues opportunities for improvement and promotes a strong culture of Quality awareness and GMP compliance.

Key responsibilities:

  • Provides general direction and support and acts as point of escalation for QA staff and customers.

  • Ensure objectives are met an expectations align with customer quality agreements, Lonza SOPs (Standard Operating Procedures) and regulatory requirements

  • Partners with internal customers to assess and resolve higher issues with Change Controls, Deviations, CAPAs and Investigations.

  • Hires staff, provides performance feedback, coaches, mentors and supports career development opportunities.

  • Oversee and support lot release activities, including batch disposition.

Key requirements:

  • Bachelor’s Degree required, life science disciple or similar preferred.

  • Strong experience in GMP (Good Manufacturing Practices) environment, within Quality Assurance of Quality Systems.

  • Experience in the Biopharma industry is preferred.

  • Prior supervisory or management experience required.

  • Extensive knowledge of GMP, FDA (Food and Drug Administration) and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) regulations.

  • Experience with Trackwise, SAP, Syncade, LIMS (laboratory information management system) and MS Suite preferred.

  • Results oriented leader with proven team management skills, excellent communication skills and ability to effectively manage challenging workloads and changing priorities for the team.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R37185
Similar Jobs