Section Manager, Quality Management Systems

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 section Manager, QMS you will be responsible for the coordination of the Quality Systems in the Quality organization. This role is responsible for results in terms of product quality and conformance to regulations and Lonza quality policies.

**Key responsibilities**:

- Supervise the day-to-day operation of Quality System team, approved Quality Assurance SOPs / Policies for a large scale, multi-product, and GMP biotech contract manufacturing facility.
- Own and lead special projects, often complex in nature.
- Involvement in global harmonization/ efficiency projects; begin to lead aspects of global projects within specific areas.
- Mastery and knowledge of Quality Management Systems and processes also a source of expertise in cGMP and compliance to others
- Strong understanding of advanced cGMP and develop others in understanding advance cGMP
- Identify problems related to Quality Management Systems, troubleshoot and complete or coordinate corrective action
- Review more complex decisions with supervisor and other departments on issues pertaining to Quality Management Systems
- Strong planning and prioritization of activities for self and team without supervision
- Communicate quality operations and compliance perspective effectively to management.
- 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
- Any other tasks as and when assigned by supervisor.

**Key requirements**:

- Degree or higher from recognized institution with significant years of experience in Validation /Quality unit in the pharmaceutical/biotech industry
- Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
- Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
- Significant years of QA, Validation background with experience in leading a small team
- Experience in Computer System Validation (or highly IT savvy) will be an advantage.
- A good understanding of Quality Management Systems, Quality IT system including Trackwise, Document management and Training systems.
- Good leadership and interpersonal skills, Effective communicator (oral and written).

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 achieve 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: R54369**: