Global Quality Compliance Senior Professional

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 role support the overall Lonza strategy to gain and maintain the license to operate, lowering quality and compliance risk by performing audit, advising the sites to reach an optimum state of compliance.

Perform Supplier Quality assessments/ audits of critical Suppliers and Contractors to annual plan and follow up on agreed upon CAPAs.

Ensure the uninterrupted supply of materials and services to Lonza within area of responsibility by assessing the quality of the Suppliers and their ability to meet defined requirements utilizing tools such as Quality Risk Management (QRM), supplier assessment/audit, change management, and complaint/deviation trend management.

Key responsibilities:

  • Develop audit plans based on risk, taking into account current regulatory focus and business needs.

  • Perform Supplier Quality assessments/ audits of Suppliers and Contractors to annual plan and follow up on agreed upon CAPAs

  • In terms of inspection readiness, support specific site preparation and/or remediation

  • Ensure that Change requests, either from the Supplier or from Lonza are managed according to the Quality Agreement and Lonza SOPs from receipt, through to the implementation and closure

  • Assure issues are timely classified, communicated to the supplier and to key stakeholders

  • Promptly notify and escalate to management any potential quality or regulatory issues that may affect product quality or regulatory compliance

  • Participate in the Reporting on QA Supplier performance - this is to include Risk Assessment ranking and managing of defined KPI’s. Monitor Key Performance Indicators and ensure work is performed in a consistent manner against harmonized expectations. Initiate corrective actions when necessary and perform follow-up on resulting measures

  • Support Lonza QMS and SOPs for Global Supplier Quality as assigned

  • Responsible for mitigating quality trends and driving continuous improvement for processes and product quality performance for assigned suppliers. Support Regional Head to find solutions to complex manufacturing, quality and negotiation problems

  • Participate in or lead Quality/Compliance projects aligned with the company strategy and group objectives

Key requirements:

  • University/academy ( B.sc or M. Sc) degree in Biochemistry, Chemistry, Pharmacy, Microbiology or equivalent

  • Extensive experience in the pharmaceutical, biopharmaceutical or related industry

  • Strong knowledge in cGMPs requirements, ISO standards and understanding of regulatory requirements

  • Proven track record with FDA, EMEA and other Health Authorities

  • Auditing experience (internal / external) manufacturing facilities, equipment, laboratories and service providers)

  • Experience in Supplier Qualification and Supplier Monitoring

  • Strong understanding of risk assessment and risk management fundamentals/tools

  • Preferably auditor certification by an industry recognized body e.g. ASQ

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: R43897