Quality Assurance Manager, Viral Vector
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 Houston’s 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 an exciting opportunity in Quality Assurance(QA) group. The QA Manager Viral Vector will oversee and provide guidance and leadership for the Quality associates tasked with providing direction during the execution of the batches and reviewing the corresponding GMP documentation generated during the manufacturing of the batch. The individual who fills this role must be a strong partner with the Manufacturing Operations team (Viral Vector).
The QA Manager must also be a strong partner with clients to ensure that project and delivery timelines and expectations for product quality and GMP compliance are met. Prior experience in Quality Leadership in the pharmaceutical industry is required; experience with cell therapy and/or gene therapy is desired, but not essential. A strong foundation in application of GMPs in a drug substance or drug product manufacturing environment is critical, as is an ability to quickly assess facts and make the appropriate decision.
- Manage and provide guidance and leadership for the Quality Associates tasked with providing direction during the execution of the batches and reviewing the corresponding GMP documentation generated during the manufacturing of the batch.
- Develops, directs, and maintains quality systems in support of CT/GT manufacturing in a manner consistent with global quality systems, Lonza Corporate requirements and standards and current regulatory requirements, (primarily US FDA and European requirements) and others as needed. Quality systems include but are not limited to audits and inspections, documentation and records management. Interfaces with site QA functions to support or develop appropriate interfaces with the site-based QA systems.
- Develop working relationships with other site functions for support of equipment, facility, utility, cleaning services and computer validation/qualification.
- Oversees all aspects of QA front facing operations within the Viral Vector facility, including but not limited to executed batch record review, on the floor QA support, MODA data review, quality oversight for APSs and act as first line of support for troubleshooting.
- Builds and maintains expertise in the QA Ops teams, including development of staff.
- Applies aseptic manufacturing experience, including aseptic process validation, to ensure that CT/GT operations meet customer and regulatory expectations and requirements for aseptic manufacturing at all phases of product development.
- Perform other duties as assigned.
- Bachelors’ degree required
- Minimum 8 years Biopharmaceutical Manufacturing experience and/or Quality Operations or Quality Systems working in a GMP environment
- GMP compliance knowledge including knowledge of 21 CFR 210, 211, 820, and FDA Guidance on Aseptic Processing. Knowledge of ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred. Commercial GMP experience is preferred
- Experience with Cell Therapy and/or Gene Therapy is desired but not essential
- Must have strong management and interpersonal skills with the ability to build a successful team.
- Demonstrates skills in problem solving and providing solutions.
- Must have strong organizational skills and be able to manage and prioritize multiple projects at one time
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.