Senior QA Compliance Specialist

Lonza Group; Geleen; On-site; EUR 47,000 - 65,000; Full time

Benefits offered by this job

Inclusive workplace

Competitive compensation

Cross-functional collaboration

Career development opportunities

Location-based benefits

Job summary

Lonza Group is seeking a Senior QA Compliance Specialist for our Geleen site in the Netherlands to reinforce the Quality Management System and GMP compliance.

You will drive quality events oversight, risk management, and training, collaborating across cross-functional teams to sustain inspection readiness and continuous improvement.

Qualifications

• 5+ years of experience in quality management, quality systems, or compliance within GMP-regulated pharma/biotech.
• Strong experience managing quality events including deviations, CAPAs, change requests, investigations, and audits.
• Solid knowledge of QMS principles, GMP requirements, risk management, and inspection readiness.
• Experience supporting audits/regulatory inspections; sterile manufacturing experience is a plus.
• Strong analytical, problem-solving, decision-making and stakeholder management skills.

Responsibilities

• Provide oversight of the site's Quality Management System, including quality events, risk management activities, and compliance programs.
• Lead the Deviation Review Board and review and approve systemic quality events, including deviations, CAPAs, change requests, investigations, and audit commitments.
• Author, review, and maintain QMS documentation and support implementation of site and global quality standards.
• Review and approve quality risk assessments and support risk management activities.
• Support internal and external audits, regulatory inspections, and ongoing inspection readiness activities.
• Deliver training on QMS and compliance topics to strengthen GMP knowledge and culture.
• Identify and implement improvements to quality systems and compliance processes with cross-functional stakeholders.

Skills

Quality management

Quality events management

Stakeholder management

Training delivery

Analytical thinking

Education

Bachelor’s degree in life sciences

Job description

As a Senior QA Compliance Specialist, you will play a key role in maintaining and strengthening the Quality Management System (QMS) at our Geleen site. As a subject matter expert in QMS and quality event processes, you will help ensure GMP compliance, support inspection readiness, and drive continuous improvement across the site.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to work cross-functionally and contribute to continuous improvement within a global life sciences organization.
• A variety of benefits dependent on role and location.

The full-time annual base pay for this position in the Netherlands is expected to range between EUR 46,500 and EUR 65,100. Initial salary placement within this range will be determined based on role-related factors such as experience, qualifications, and expected contribution.

What you will do:

• Provide oversight of the site's Quality Management System, including quality events, quality risk management activities, and compliance programs.
• Lead the Deviation Review Board and review and approve systemic quality events, including deviations, CAPAs, change requests, investigations, and audit commitments.
• Author, review, and maintain QMS documentation and support implementation of site and global quality standards.
• Review and approve quality risk assessments and support the implementation of risk management activities.
• Support internal and external audits, regulatory inspections, and ongoing inspection readiness activities.
• Deliver training on QMS and compliance topics, helping strengthen GMP knowledge and a culture of quality across the site.
• Identify and implement improvements to quality systems and compliance processes while working closely with cross-functional stakeholders.

What we are looking for:

• At least 5 years of experience in quality management, quality systems, or compliance within a GMP-regulated pharmaceutical or biotechnology environment.
• Strong experience managing quality events, including deviations, CAPAs, change requests, investigations, and quality risk management activities.
• Solid knowledge of QMS principles, GMP requirements, risk management, and inspection readiness.
• Experience supporting audits, regulatory inspections, and broader compliance programs; experience in sterile manufacturing is an advantage.
• Strong analytical, problem-solving, decision-making, and stakeholder management skills, with the ability to work effectively across functions.
• Experience developing or delivering training on quality and compliance topics.
• A bachelor's degree or equivalent qualification in a relevant discipline, ideally supported by experience in a life sciences environment.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.