Senior QA Compliance Specialist

Lonza; Geleen; On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance-based compensation

Cross-functional collaboration

Job summary

Lonza in Geleen seeks a Senior QA Compliance Specialist to strengthen the Quality Management System, lead quality events, and support inspections. You will ensure GMP compliance and drive improvements across the site.

Responsibilities include overseeing QMS documentation, risk assessments, and training, with cross-functional collaboration to uphold quality across operations. A strong life sciences background and regulatory experience are expected.

Qualifications

• At least 5 years of experience in quality management, quality systems, or compliance within GMP-regulated environments.
• Strong experience managing quality events including deviations, CAPAs, and investigations.
• Knowledge of GMP requirements and inspection readiness.
• Experience supporting audits and regulatory inspections; sterile manufacturing knowledge is a plus.
• Ability to train and influence stakeholders across functions.

Responsibilities

• Oversee the site's Quality Management System, including events, risk management, and compliance programs.
• Lead the Deviation Review Board and approvals for quality events and audits.
• Author and maintain QMS documentation and support standards implementation.
• Review quality risk assessments and support risk management activities.
• Support audits, inspections, and inspection readiness activities.
• Deliver training on QMS and compliance topics to strengthen GMP knowledge.
• Identify improvements to quality systems and cross-functional processes.

Skills

GMP knowledge

QMS principles

Quality events mgmt

Audit support

Cross-functional collaboration

Training delivery

Education

Bachelor's degree in life sciences

Job description

Netherlands, Geleen

Senior QA Compliance Specialist

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 list of our global benefits can be found here: https://www.lonza.com/careers/benefits .

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.

Reference: R79339