Associate Director, QA- Cell and Gene Therapy
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 QA (Quality Assurance) Asset Head of the site Cell and Gene Therapy (CGT) group is the leading source of Quality and GMP (Good Manufacturing Practices) related expertise within the group and is responsible for providing the strategic leadership and management for the CGT Quality organization. This role will provide leadership to the CGT Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a team
- Develop and execute the Quality strategy commensurate with the overall plan for the company. Ensure alignment with customer needs and linkage with the overall Quality and business strategies.
- Implement continuous improvement initiatives to drive Quality programs and ensure maximum productivity. Ensure systems meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
- Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines.
- Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interactions. Oversee all partner and regulatory authority audits and inspections and corrective action programs in response thereto
- Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Lonza’s long-term objectives in CGT
- Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions.
- Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent the Lonza on quality and cGMP compliance issues that are specific to the site
- Serve as the site CGT Quality expert, providing solid, well-informed, actionable Quality support to CGT Operations, R&T, and other functions as requested.
- Bachelor’s Degree in a Life Sciences, Engineering or Quality Management or related science discipline
- Substantial related experience in GMP manufacturing and Quality Management of products regulated by FDA (Food and Drug Administration), CBER (Center for Biologics Evaluation and Research) or CDER (Center for Drug Evaluation and Research) or EMA (European Medicines Agency).
- Significant experience in senior leadership positions. Experience in Quality Assurance applicable to investigational drug manufacture and aseptic processing is highly desired.
- Expert knowledge of GxP, ISO Standards, FDA regulatory requirements applicable to FDA regulated products; European regulatory requirements as applied to biologicals and sterile product manufacturing.
- Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
- Regulatory knowledge of CBER, CDER and CDRH, EMA
- Strong knowledge of current industry trends and has the ability to use the latest technologies
- Working knowledge of: Aseptic practices and clean room design/operations, auditing techniques.
- Excellent organizational and computer software skills
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.