Quality Assurance Manager - Audit & Inspection
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 Quality Assurance Manager - Audit & Inspection to join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.
Reporting to the Head of External Quality, in this role you will have specific responsibility for overall regulatory, customer inspection and audit management. The brief will focus on leading, managing and overseeing regulatory inspections, customer audits, managing, and supporting Slough site leadership throughout the inspection/audit process to ensure optimal outcomes and a state of continuous inspection readiness.
Providing a focal point for all inspection and audit-related activity and for coordinating follow-up and responses to observations, a key priority will be to improve the efficiency with which these activities are managed. As well as reviewing current practices, you will be encouraged to collaborate with colleagues from across the Lonza network to incorporate their learnings. You will also need to build and maintain productive relationships with the Global Quality Assurance (GQA) team to enhance knowledge sharing and improve response times.
- Manage regulatory inspections and customer audits for the Slough site.
- Advise, guide and support the site in the overall inspection management
- Manage site preparation for inspections and audits
- Organise and run the Back Room during audits
- Manage any outcomes/findings, ensure appropriate responses liaising with customers and Global Quality Assurance (GQA)
- Provide guidance for timely remediation and support response writing
- 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
- Prepare and review regulatory inspection evidence files
What we need you to have:
- Bachelors degree (or equivalent) in a scientific or QA-related discipline
- Significant experience working within QA roles in GMP-regulated pharmaceutical – ideally biologics or biopharmaceutical – environments
- Significant experience managing regulatory (e.g., MHRA & US FDA, etc.) inspections.
- Experience working with drug substances
- Ability to meet strict deadlines.
- Ability to work in team and solo capacity.
- Significant experience in risk management and project management.
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.