Qualification and Validation Manager - 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 QA Qualification and Validation manager drug product, you will be responsible for the Qualification and Validation of a new drug product facility, ensure that decisions are fully supported by global and local Quality and Regulatory units, escalate issues in an open and timely manner and take leadership for their resolution.
- Provide Quality input to the project team in the area of qualification / Re-qualification & validation / Re-validation (equipment, room, process).
- Lead the preparation, review and approval of the validation master plan.
- Prepare and perform Qualification and Validation activities in compliance with cGMP regulations and specification requirements.
- Write, Review and Execution of Qualification / Validation protocols (OQ, PQ).
- Review and approval of third party generated protocols and reports.
- Provide regular updates on qualification activities and performance.
- Leading/participate in change controls and deviations. Supports and approves quality risk analysis (e.g. GMP-FMEA)
- Perform independent review and approval of qualification and validation document.
- Identify opportunities for optimization of operational procedures in order to improve quality and efficiency within area of responsibility
- Conduct training for Qualification & Validation processes
- Responsible to generate, review and or approve CAPAs, and other applicable documentation as part of the identified tasks during the qualification and validation activities
- Support project change control within the project scope
- Take part at audits and inspection
- Continuously monitor key performance indicator
- Master Degree in a Quality Management, Engineering or related science discipline
- Extensive experience in a regulated pharmaceutical industry including engineering, manufacturing, quality assurance, quality control, R&D and/or drug regulatory affairs.
- Experience of chemical and biological GMP API manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements.
- Proven management experience in NMPA regulated environment, and have an excellent working knowledge of current ICH, PIC/S, NMPA， EU and US regulatory requirements and their implementation.
- Leadership role in operations readiness including the onboarding and training of new staff – both quality and operations.
- Excellent knowledge of computer systems (i.e. Microsoft Word, Excel, PowerPoint, and Visio) with demonstrated skills in the use of information management systems in a GxP environment (TrackWise, DMS, LIMS, SAP etc.).
- Effective influencing skills. Ability to communicate quality and compliance requirements to varying levels and functions of the organization. Strong collaborative mindset.
- Proven ability to lead, mentor and coach direct reports and teams with or without direct line responsibility.
- Ability to solve problems, understanding details and strategic picture, providing practical solutions. Strong analytical and investigative skills.
- Strong verbal and written communication skills (English and Chinese).
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.