Section Manager, QA

2 weeks ago

Tuas, Singapore Lonza Full time

Singapore, Tuas SingaporeToday, 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.

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.

As a QA Section Manager your will provide oversight to supply chain in large scale, multi-product, GMP biotech contract manufacturing facilities.

**Key Responsibilities**
- Participate in supply chain oversight activities (eg approval of material packages, supplier management, supplier complaints, oversight of warehouse)
- Liaise with global for supplier audit management.
- Approve deviation investigations, change controls, CAPA.
- Identify problems, troubleshoot and complete or coordinate corrective action.
- Strong planning and prioritization of activities for self and team without supervision
- Own and lead special projects, often complex in nature.
- Review more complex decisions with supervisor and other departments
- Mastery and knowledge of processes is recognized by colleagues as a source of expertise.
- Communicate quality issues and compliance perspective effectively to management and / or global counterparts.
- Strong understanding of advanced cGMP and develop others in understanding advance cGMP.
- 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.
- Develop skills as an internal GxP auditor, as required.
- Subject Matter Expert for internal, customer or regulatory audits.
- Provide support in regulatory inspections and customer audits as required.
- Make suggestions for cost savings.
- Any other tasks as and when assigned by supervisor.

**Key Requirements**:

- Engineering / Science Degree from recognized institution with 10+ years of experience in Quality Unit in the pharmaceutical / biotech industry
- Familiarity with Regulatory requirements and local Codes & Standards (e. g., FDA, EMEA, andlCHQ7)
- Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
- Good leadership, interpersonal and exhibit good quality decision making skills.
- Effective communicator (oral and written)
- Meticulous and Systematic with Analytical Mind
- Team player, with strong focus on safety, quality and timeline Analytical Mind

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.

**Reference: R55513**:

- Apply

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