Lonza

QA Project Manager

Location: Oss

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula for 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 QA Project Manager you support the building and maintenance of the Synaffix Quality System and assist manufacturing and distribution from a quality and compliance perspective including reviewing and releasing products. Furthermore the QA Project Manager supports all GMP compliance matters (e.g., acting as the contact person for customers and CDMOs regarding compliance questions) and promotes adherence to and continuous improvement of Quality Systems. Additionally you ensure an appropriate level of quality oversight within Synaffix.

Key responsibilities:

• Build and maintain the Synaffix Quality System ensuring GMP compliance.
• Support manufacturing and distribution activities, reviewing and releasing products.
• Manage central initiatives to streamline and enhance quality functions.
• Represent the QA department in cross-functional teams, liaising with Lonza quality departments.
• Lead, support, and participate in internal, customer, supplier, and regulatory audits.
• Handle customer communications regarding changes, deviations and out of specifications.
• Assess, review, and approve quality records such as deviations, change controls, CAPAs and investigations.
• Author, review, and approve GMP-relevant documents and SOPs.
• Review and approve completed Master Batch Records, preparing batch release packages.
• Promote continuous improvement programs for Quality Management Systems.

Key requirements:

• Bachelor’s or Master’s Degree in Life Sciences (e.g., chemistry, biotechnology, or a related field).
• 3-6 years of experience as a QA officer or Project Manager within a QA department.
• Experience in the pharmaceutical industry is essential.
• Broad knowledge of Quality standards (e.g., ICH Q7, EU GMP part 1).
• Strong analytical, problem-solving and decision-making skills.
• Excellent communication, interpersonal and teamwork skills.
• Attention to detail, accuracy and focus on quality.
• Ability to work independently and manage pressure effectively.
• Proficiency in MS Office and quality software tools.

Join us at Lonza AG, where your contributions will help us fulfill our dedication to improving lives globally. Apply now and be part of our journey to deliver outstanding quality products and services!

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.