Vacature Senior Compliance Specialist

Senior Compliance Specialist in Geleen

Location

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 Senior Compliance Specialist, you will play a vital role in maintaining our commitment to excellence by reviewing and approving compliance-related systemic documentation and overseeing site compliance. In this dynamic position, you will engage in crafting, reviewing, and approving essential documentation within our Compliance and Quality Management System (QMS). Your expertise will be crucial in monitoring and analyzing Quality events, managing the Site Risk Register, conducting comprehensive risk assessments, and supporting both internal and external audits. You will also be a key player in supporting daily compliance activities, ensuring that all procedures and policies are upheld with the highest standards. If you're passionate about quality and compliance, and you thrive in a collaborative environment, we invite you to join our dedicated team and make a significant impact on our mission!

What you’ll do:

• Oversee systemic quality deviations and corrective/preventive actions (CAPA) and act as a Subject Matter Expert and system Administrator or super user of Quality Management Systems and Lead Deviation Review Board
• Manage and approve documentation within the Quality Management System (QMS)
• Review and approve risk assessments
• Support internal and external audits and inspections and preparation of the site for regulatory inspection
• Provide training on QMS and compliance to enhance team and site knowledge
• Identify and implement improvements in compliance processes
• Foster a culture of compliance and continuous improvement

What we’re looking for:

• Bachelor’s degree in a relevant discipline, preferably in life sciences
• Minimum 5 years experience in quality management and compliance in a pharmaceutical environment (e.g., cGMP)
• Preferable to have experience with sterile manufacturing
• Extensive knowledge of quality standards, risk management, and audit processes
• Strong analytical skills and attention to detail
• Excellent communication and teamwork abilities
• Experience in training personnel on quality and compliance topics
• Familiarity with deviation and CAPA management

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.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.