Quality Assurance Project Lead
United States, Houston (Texas)
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.
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 in the Quality Assurance group. The QA Project Lead position will involve collaboration with cross-functional teams, and other Lonza sites in collaboration with the QA Project Manager (PM), to articulate the Quality and Compliance position as well as engage as the Quality lead for strategic internal and external client relationships and issues during new client introduction to Lonza and QMS initiatives.
- Verification of R&T project design, planning and execution of R&T projects to ensure compliance with current ISO/cGMP requirements
- Provide immediate support to operations and quality control staff to address compliance related concerns with regard to specific projects as they transition from Research to Operations.
- Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
- Audit internal quality system elements of research and development projects to ensure technical transfer to manufacturing and operational support areas is completed on time and in compliance with international cGMP regulations.
- Provide oversight for compliance of validation master plan, design documentation, technical transfer requirements and review of final reports.
- Act as QA representative on cross-functional, conference calls, meetings and other standard means of communication.
- May need to direct the work of others both cross-functionally and within QA.
- Collaborate with internal QA management and team members to ensure alignment with current site SOP, policies and procedures.
- Maintain sense of urgency to manage QA aspects of project to ensure timelines are met.
- Bachelor’s degree in life sciences required. Master degree or PhD preferred.
- Advanced experience in direct QA and a working knowledge of cell culture, cell culture starting materials and aseptic processing experience required ,or an equivalent amount of aseptic processing , cell therapy or cell culture manufacturing experience.
- GMP compliance knowledge including knowledge of 21CFR210, 211, 610 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred.
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.