Head of Quality, Drug Product
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 is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market.
As Head of Quality - Drug Product, you will lead quality organization (QA, QC) at the Site for Drug Product to accomplishes corporate business objectives by developing site quality systems and enforcing Regulatory compliance. You also assure that the site remains under control with respect to GMP, collaborating with Operations to solve quality issues. Acting as Key Account Quality Manager for selected customers, you will lead & support Audits & Regulatory Inspections at the Site and be the member of the Drug Product Leadership team and the Site Quality Leadership team.
- Leading source of Quality and GMP related expertise within the site and is responsible for providing the strategic leadership and management for the Site`s Quality Drug Product organization
- Provide leadership to the Drug Product 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, NMPA, 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 interaction. 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
- 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, NMPA, Swissmedic, FDA, EMA and other regulatory authorities. Represent the Lonza on quality and cGMP compliance issues that are specific to the site
- Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Operations, and other functions as requested
- Bachelor's Degree in a Life Sciences, Engineering or Quality Management or related science discipline
- Extensive related experience in GMP manufacturing and Quality Management of products regulated by FDA CBER or CDER or EMA with solid experience at a senior leadership position. Experience in aseptic processing is a pre-requisite.
- A change leader by visibly demonstrating commitment to change, and aligning and helping others embrace change, ability to translate corporate strategy into critical success factors and creates effective implementation plans
- Good communication and presentation skills.
- Strong influencing skills
- Good Written & Oral English skill
- 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 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.