Senior Manager, Quality Systems
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.
Lonza Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity within our Quality Group for a Senior Manager for Quality Systems. This position is responsible for providing leadership and managing all the quality systems for the day to day commercial operations. The incumbent will be responsible for implementing and executing the internal, customer audit and regulatory inspections program. Must have a strong working knowledge of GMP requirements and ability to present and defend Lonza’s Quality Systems to existing and prospective customers, regulatory agencies and corporate compliance groups.
- Manages all aspects of QA Quality Systems for a Phase III/Commercial GMP Viral Therapy/Cell Therapy (VT/CT) contract manufacturing facility
- Develops and implements commercial quality systems for the facility including but not limited to Document Control and Recordkeeping, Deviation, Complaint and CAPA systems, Change Control system, Internal and Customer Audit program, Regulatory inspection program, Risk Management program, APR/PQR program for commercial products, Supplier Quality program and GMP Training program.
- Ensures that Quality Systems for the VT/CT Manufacturing unit meet Lonza Global Quality Standards and applicable regulatory requirements.
- Manages and plans the work of the Quality Systems group. Writes and/or reviews and approves Quality systems related SOPs.
- Participates in VT/CT related project teams as required.
- Meets with clients on a regular basis to ensure that QA systems meet their expectations.
- Leads, facilitates or participates in Regulatory Inspections and client audits.
- Ensures Supplier Quality program is in place by coordinating site needs with Lonza Global Supplier Quality team.
- Selects, trains, and supervises staff to perform functions consistent with procedural and business requirements. Develops, mentors, and coaches direct reports as well as coaches other site personnel on Quality Systems use.
- Assesses implementation and use of site Quality systems on a regular basis and reports metrics to Site Quality Council with proposed actions if required.
- Leads continuous improvement efforts around the design and use of the site Quality Systems.
- Participates in cross-site forums and contributes to Lonza Pharma-Biotech (LPB) and Business Unit Quality policies and procedures as requested.
- BA/BS in relative scientific or technical discipline field
- Preferred area of study: Science or engineering, biological sciences preferred
- Pharmaceutical background is required
- Certified Quality Auditor a plus
- Extensive experience in Quality Assurance, Quality Systems or Quality Operations in a commercial cGMP environment is required.
- Advanced experience in Management or Supervision of QA teams is required
- Advanced experience managing quality issues related to biologics bulk drug substance and/or drug product manufacturing in a commercial environment.
- Experience managing regulatory inspections
- Working knowledge of global cGMPs related to all aspects of Biologics manufacturing, including ICH Q7 and FDA/EMA regulations related to cell/gene therapy and aseptic manufacturing of drug product.
- Working knowledge of all Quality Systems required for a biologics manufacturing facility.
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.