Head of Quality Control (QC Biologics)
Head Quality Control (QC) Biologics
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 Head Quality Control (QC) Slough provides the strategic leadership and management of all GMP analytics at the Slough site, including batch release testing, stability (pilot, clinical and commercial), raw materials, in-process testing, bioassay (method transfer and validation) and microbiology.
- in close collaboration with the Analytical Departments Heads and Site Leadership Team members.
- Input and execute the Biologics QC and Analytical Science and Technology (AS&T) strategy including implementation of associated IT systems commensurate with the strategic growth of the Biologics business and in alignment with customer needs, latest technology developments.
- Develop, implement and monitor QC programs, policies and procedures to ensure compliance with cGMP standards, corporate policies, US FDA and other regulatory requirements.
- Drive operational excellence/Lean lab and innovation/automation in QC across site and in line with industry benchmarks.
- Serve as the point person with industry partners regarding QC and AS&T matters, customer satisfaction levels and regulatory authority interaction..
- Lead the implementation of a consistent QC and AS&T strategy across the site in line with BU and customer needs.
- Provide leadership to the QC department to ensure that pro-active solution orientated teamwork, high morale and innovation are fundamental components of the team performance. Foster a fact driven and forward looking working culture.
- Provide strategic direction for the QC department and ensure continuous improvement of processes.
Ensure consistent implementation of an effective QC organization at the site in line with asset needs.
- Ensure consistent management of capacity planning and schedule adherence by using innovative and standardized tools and in close collaboration with Site Leadership Team members.
- Accountable for GMP analytics at Slough site, including batch release testing, stability (pilot, clinical and commercial), raw materials, in-process testing, bioassay (method transfer and validation) and microbiology.
- Maintain alignment, where needed, with the global network for QC and analytics
- Implement continuous improvement initiatives and strategic projects to drive QC programs and ensure high productivity and efficiency through adoption of Lean Lab, consistent usage of LIMS, advanced science and technology and automation in line with business needs.
- Accountable for the ownership of Lonza platform methods, encompassing method maintenance and reagent replenishment.
- Ensure that analytical specifications are appropriate for the product through the various lifecycle phases.
- Ensure oversight of contract analytical testing laboratories.
- Member of the Site Leadership Team representing QC.
- Ensure inspection and audit readiness at any time and drive quality beyond compliance improvement programs.
- Ensure health and safety requirements are fully implemented.
SKILLS AND EXPERIENCE REQUIRED:
- Master’s Degree chemistry or other related science discipline.
- 10 or more years of experience in Quality Control and Quality Management in the Pharmaceutical and/or CMO Industry, at least 5 years in a senior management role with particular emphasis on QC, standardization and continuous improvement.
- Strong knowledge of current industry trends and has the ability to use the latest technologies.
- Expert knowledge on Lean/Six sigma and Lab automation.
- Expert knowledge of GxP, ISO Standards, FDA regulatory requirements applicable to FDA regulated products; European regulatory requirements as applied to biologicals and sterile.
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.