Section Manager, QA

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 is 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.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience - we, in Singapore are proud to be part of this global network.

The Section Manager, QA Cell Therapy will be responsible to provide oversight to the manufacturing in the Cell and Gene Therapy contract manufacturing facility.

**Key responsibilities**:

- Supervise the day-to-day operation of approved Quality Assurance Sops I Policies for cell and gene therapy contract manufacturing facility
- Provides support in backrooM/Front room, participate and front in regulatory
inspections and customer audits as required
- Mastery and knowledge of processes is recognized by colleagues as a source of expertise
- Strong understanding of advanced CGMP and develop others in understanding advance CGMP
- Is recognized by colleagues as a source of expertise in CGMP and compliance
- Identify problems, troubles hoot and complete or coordinate corrective action
- Review more complex decisions with supervisor and other departments
- Strong planning and prioritization of activities for self and team without supervision
- Communicate quality operations and compliance perspective effectively to management
- Involvement in global harmonization/ efficiency projects; begin to lead aspects of global projects within specific areas
- Understand and articulate company business strategy. Maintain a broad view of the
- business, recognize changes and trends in the appropriate area in which the individual operates
- Own and lead special projects, often complex in nature
- Make suggestions for cost savings
- Any other tasks as and when assigned by Manager/Director.

**Key requirements**:

- Extensive experience in in Operations/ Validation / Quality Unit in the pharmaceutical / biotech industry
- Degree from recognized institution
- Relevant QA Operations background from the Biopharma environment
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
- Good knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
- Meticulous and Systematic.
- Team player, with strong focus on safety, quality and timelines.

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.