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Lonza

Senior Specialist, Compliance (Audit Management), QA

Reposted Yesterday
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In-Office
Singapore
Senior level
In-Office
Singapore
Senior level
Oversee Quality Assurance activities, review documents, support inspections, manage compliance, and drive continuous improvement initiatives in a biopharmaceutical setting.
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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.

Join our best-in-class high performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting-edge biotechnology and innovation. Learn new skills and capabilities. Grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.

What you’ll get

  • An agile career and dynamic working culture in a global life sciences leader.

  • An inclusive and ethical workplace that values diversity and integrity.

  • Competitive compensation programs that recognize high performance.

  • Professional growth opportunities through cross-functional projects and global exposure.

  • Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums.

  • Company transport provided from designated MRT locations to and from the Tuas site.

  • Access to Lonza’s full suite of employee benefits: www.lonza.com/careers/benefits

What you’ll do

  • Oversee day-to-day Quality Assurance activities in compliance with approved SOPs and cGxP requirements within a multi-product contract manufacturing facility.

  • Review and approve SOPs, protocols, reports, and quality records.

  • Collaborate with cross-functional teams to support site projects and resolve issues.

  • Coordinate effectively across departments to manage multiple concurrent activities.

  • Troubleshoot issues, identify process gaps, and drive continuous improvement initiatives.

  • Support and participate in regulatory inspections and customer audits, including front-room/back-room activities, audit walkdowns, and response preparation.

  • Maintain strong understanding of advanced cGMP principles and uphold data integrity standards.

  • Take on supervisory responsibilities in the absence of the supervisor.

  • Contribute to business strategy awareness by understanding broader operational needs and industry trends.

  • Develop skills as an internal GxP auditor and qualified trainer; serve as a Subject Matter Expert in key areas.

  • Own and manage documents related to assigned Quality Processes.

  • Perform other related duties as assigned.

What we’re looking for

  • Bachelor's degree or higher in Life Sciences or Pharmaceuticals, with significant experience in Validation and Quality roles within the Biopharmaceutical industry with 7 – 10+ years of experience

  • Familiar with regulatory requirements and local codes & standards (e.g., FDA, EMEA, ICH Q7).

  • Strong knowledge of quality management systems (QMS) and practical GMP operations in a biopharmaceutical or GMP-regulated facility.

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.

Top Skills

Cgxp
Emea
Fda
Gmp
Ich Q7
Quality Management Systems
Sops

Lonza Singapore Office

35 Tuas South Ave 6, Singapore, 637377

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