Quality Systems Manager

1 week ago

West Region, Singapore Lonza Biologics Tuas Pte Ltd Full time $80,000 - $120,000 per year

Today, Lonza is a global leader in life sciences operating across five 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.

As a Specialist, QA (Quality External) at Lonza, you will monitor and support day-to-day Quality Assurance activities in accordance with approved SOPs and policies for a multi-product, cGxP contract manufacturing facility. In this fixed term contract role, you will provide QA oversight in quality compliance and audits, support regulatory inspections, and collaborate cross-functionally to ensure the highest level of quality and compliance with cGMP standards.

What you'll get

  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • Daily company bus from the MRT location near your home to and from the Tuas site.
  • Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums.
  • Access to Lonza's full global benefits portfolio:

What you'll do

  • Support and participate in Regulatory Inspections and Customer Audits, including front room/backroom roles.
  • Lead complex deviation investigations and review/approve deviations, change controls, trend investigations, supplier notifications, and CAPA plans.
  • Perform material release and qualification, joint inspections, and vendor investigation reviews.
  • Coordinate and deliver Supplier Quality Agreements in a timely manner.
  • Own documents for assigned Quality Processes and support document management activities.
  • Support continuous improvement, troubleshooting, and process pathway development for strategy improvements.
  • Ensure adherence to data integrity principles in line with Lonza policies, proactively identifying and improving data integrity processes.
  • Perform other duties as assigned by supervisor.

What we're looking for

  • Degree or Diploma in Science, Science-related, or Engineering discipline.
  • Experience in Quality Assurance within a cGMP manufacturing environment preferred.
  • Knowledge of Quality Compliance, audits, and regulatory inspections.
  • Strong problem-solving and troubleshooting abilities.
  • Excellent communication, coordination, and stakeholder management skills.
  • Ability to work independently while collaborating across functions.
  • Motivated and proactive with the capability to assume leadership when required.

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.

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