QA Manager - Sterility Assurance

QA Manager - Sterility Assurance

Apply locations SG - Tuas, Singapore time type Full time posted on Posted 3 Days Ago job requisition id R63423

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.

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.

This is an exciting position responsible for QA oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Cell and Gene Therapy entity. The role will provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements (FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1, “Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820).

The role will also provide strategic planning and expertise for the development and implementation of the Microbial Control Strategy. Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release.

Key responsibilities:

• Provide support and expertise to ensure that Cell and Gene Therapy (CGT) and Media preparation operations and support functions for Cleanroom management, Materials Management, Aseptic practices, Environmental monitoring (EM), Sterilisation methods, and Aseptic process simulations (APS) confidently deliver CT products to patients with the highest quality sterility assurance level.
• Review policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations and sterility failures.
• Provide Sterility assurance expertise to support APS/EM deviations and investigations, CAPAs and Complaints related to aseptic processing.
• Review sterile filter validations, integrity testing and procedures.
• Provide expert support and assessment to business partners including production, MSAT, Engineering, QC and QA assuring adequate facilities contamination prevention practices, monitoring tools are provided to production to guarantee the best EM indicator levels.
• Involvement in global harmonization/efficiency projects; begin to lead aspects of global projects within specific areas.
• Represent site in global forums from a sterility assurance perspective. Collaborate with stakeholders of different functions to lead/implement various global/site projects to support sterility assurance.
• Support regulatory and client audits as Aseptic sterility assurance subject matter expert.
• Responsible for the generation of key performance indicators, GEMBA walks, regulatory compliance and efficiency targets.
• Communicate quality operations and compliance perspective effectively to senior management.
• Understand and articulate company business strategy. Maintain a broad view of the business and recognize changes and trends in the appropriate area in which the individual operates.

Key requirements:

• Engineering/Life Science Diploma/Degree or higher from a recognized institution with significant years of QA or QC Sterile processing and Microbial experience in a similar capacity.
• GMP experience in the biologics industry is required.
• Working knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy required.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required.
• Experience in cell culture, cell or gene therapy experience is a plus.

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.