Head of Quality Assurance- Mid-Scale
United States, Portsmouth (New Hampshire)
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.
The Mid-scale Mammalian Manufacturing QA (Quality Assurance) Head will oversee all aspects of quality assurance for the manufacturing asset, ensuring that the quality systems and controls meet Lonza global standards and regulatory requirements. The individual who fills this role must be a strong partner with the Operations and site Quality Assurance groups, as well as being a strong partner with customers to ensure that project and delivery timelines and expectations for product quality and GMP (Good Manufacturing Practices) compliance are met.
- Develops and implements the overall quality strategy for the Mid-scale facility.
- Partners with the Site Director and Senior Leadership Team to ensure alignment with Manufacturing and support functions in executing the strategy.
- Acts as the lead SME for significant quality/compliance issues within the asset.
- Manages the asset QA budget and resources to maximize efficiency and maintain quality/compliance at high levels.
- Develops, directs, and maintains quality systems in support of 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 for equipment, facility, cleaning and computer validation/qualification and the site-based QA systems.
- Oversees all aspects of QA operations within the facility, including but not limited to batch record review, on-the-floor QA support, deviation investigations, change controls, Quality agreements, and SOP and master batch record review.
- Responsible for release of clinical and commercial batches.
- Ensures QA support for internal and external project and team meetings.
- For significant issues, interfaces with customers and internal groups for resolution of quality issues.
- Has decision-making authority for all asset Quality issues; informs Site QA Head of critical issues in a timely manner.
- Builds and maintains expertise in the asset QA team, ensuring development of staff.
- Applies quality/manufacturing experience, including process validation, to ensure that operations meet customer and regulatory expectations.
- Bachelor's Degree, Preferred area of study: Life sciences or Engineering
- Substantial experience in a biopharmaceutical manufacturing experience and/or quality operations or quality systems working in a GMP environment.
- Prior experience in biologics API or drug product Quality Assurance is required; experience in mammalian cell-derived biologics is desired, but not essential.
- A strong foundation in application of GMPs in a drug substance or drug product manufacturing environment is critical
- Ability to quickly assess facts and make the appropriate decision when process/product quality may be impacted.
- Significant experience in managing people in a Quality Assurance role.
- Strong knowledge in the application of cGMP requirements to biologics manufacturing processes, and purpose and function of supporting processes.
- Ability to apply cGMPs in a biologics manufacturing environment in a compliant and pragmatic manner.
- Understanding of facility design requirements and operating principles for biologics manufacturing.
- Understanding of validation/qualification principles, industry practices, and standards with ability to apply these to GMP operations as a QA leader.
- Working knowledge of all Quality Systems required for a biologics manufacturing facility.
- Demonstrated ability to oversee GMP operations, make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA activities.
- Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding.
- Able to communicate status, needs, forecasts, risks and timelines effectively to management.
- Displays a clear willingness to listen to others.
- Has good interpersonal skills and works inter-departmentally in an effective manner to achieve objectives.
- Shows commitment and dedication and strives to be ahead of schedule.
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 it is 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.