External QA Manager

United Kingdom, Slough

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

We are currently looking for an experienced External Quality Manager, reporting to the Head of External Quality and responsible for overseeing External Quality team members responsible for Customer projects.

Providing a focal point for all customer related activities and for ensuring Customer requirements are met as defined in the Quality Agreement/Statement of Work.  A key priority will be to improve the efficiency with which these activities are managed.  As well as reviewing current practices, collaborate with colleagues from across the Lonza network to incorporate their learnings.  Build and maintain productive relationships with Global Quality and Lonza Slough teams to enhance knowledge sharing and improve response times to Customers.

Take a lead role in ensuring follow up actions and communication remain focused and are managed in a timely way.  A critical aspect of this will be to ensure that activities are completed in a timely manner and to communicate timelines and status of activities to the Customer. 

Key responsibilities:

  • Manage preparation for new Customer projects, including the implementation of Quality Agreements
  • Organize and review the status of Customer projects to ensure on time performance of tasks
  • Manage any outcomes/deviations; ensure appropriate responses in compliance with the regulations
  • Work with QA and other departments to ensure that CAPA raised as a result of the above are SMART and that CAPAs are closed by the due dates
  • Responsible for leading the Site responses to the Lonza Global regulatory gap analysis
  • Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments
  • Provide QA support to initiate, participate and contribute to PQS process improvements initiatives and projects
  • Establish strong relationships with key stakeholders across the site to ensure that these goals are continuously met.
  • Apply GMP regulations consistently and use knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement activities.

What we need you to have:

  • Degree (or equivalent) in a Life science discipline
  • Significant experience working within a GMP-regulated pharmaceutical – ideally biologics or biopharmaceutical – environments and/or relevant QA experience
  • Previous QMS process design, implementation, management and utilization experience
  • Previous management experience with ability to manage a team with 4 direct reports
  • Strong experience within Risk and Project Management.
  • Demonstrate strong organizational and interpersonal skills, building relationships with effective communication, conflict resolution, critical thinking and problem solving with a keen attention to detail.

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.

Reference: R23236