Senior QA Officer (freelance)

• Quality Assurance
• Netherlands, Leiden
• 16 juli 2026
• Fulltime
• Wo
• V-195536
• €80 - €100 per hour

Senior QA Specialist – Freelance(Candidates without valid working visa for the Netherlands will not be considered)Are you an experienced Quality Assurance professional who can independently navigate a complex GMP environment? Do you enjoy taking ownership of quality processes, advising stakeholders and driving improvements across an organisation?
For an innovative biopharmaceutical organisation, we are looking for a freelance Senior QA Specialist. In this assignment, you will play a key role in maintaining and further developing the Quality Management System. You will combine hands-on QA support with quality oversight, stakeholder management and continuous improvement.

Your role
As Senior QA Specialist, you act as a trusted quality partner for operational departments, project teams and management. You independently assess quality risks, provide clear guidance on GMP requirements and ensure that quality issues are handled thoroughly and within the agreed timelines.
You will not only maintain existing processes, but also identify opportunities to strengthen the organisation’s quality systems and ways of working.
Your responsibilities include:

• Taking ownership of complex deviations, complaints, investigations and CAPAs
• Assessing the quality and effectiveness of root cause analyses and corrective actions
• Providing senior QA oversight within multidisciplinary projects
• Advising departments and management on GMP compliance, quality risks and inspection readiness
• Reviewing and approving risk assessments, validation and qualification documentation
• Reviewing batch documentation, specifications, testing records and release-related documentation
• Supporting the preparation of documentation for QP disposition
• Maintaining and improving the Quality Management System
• Developing, reviewing and approving SOPs, policies and other GxP documentation
• Identifying gaps in procedures and implementing sustainable improvements
• Leading or supporting internal audits, supplier audits and regulatory inspections
• Coordinating inspection and audit observations and monitoring the associated CAPAs
• Supporting supplier qualification, monitoring and periodic evaluation
• Acting as a subject-matter expert, trainer and coach for colleagues
• Promoting a strong quality culture throughout the organisation

Your background
You are an independent and pragmatic QA professional who knows how to balance regulatory requirements with operational priorities. You are comfortable challenging decisions when necessary and can clearly explain the quality rationale behind your advice.
You bring:

• A completed bachelor’s or master’s degree in biotechnology, chemistry, pharmaceutical sciences, life sciences or a comparable discipline
• At least five years of relevant experience within a GMP-regulated pharmaceutical or biopharmaceutical environment
• Several years of hands-on experience in Quality Assurance
• Strong knowledge of current GMP, GDP and relevant European pharmaceutical legislation
• Experience within sterile manufacturing, biologicals, vaccines, injectables, parenteral products or ATMPs
• Demonstrable experience with deviations, CAPAs, change controls, risk assessments and quality documentation
• Experience reviewing qualification and validation protocols and reports
• Experience conducting or supporting internal, supplier or regulatory audits
• The ability to independently manage complex quality topics and multiple stakeholders
• Strong communication and influencing skills
• Professional proficiency in English, both written and spoken
• Willingness to travel occasionally for supplier audits or other quality activities
• Dutch working visa is required

What makes this assignment interesting?
This assignment offers the opportunity to make a visible impact within a technically advanced and highly regulated environment. You will work on a broad range of QA topics and have the autonomy to improve processes, strengthen compliance and help shape the organisation’s quality culture.

You can expect:

• A senior and influential QA assignment
• Considerable independence and responsibility
• Exposure to complex biopharmaceutical manufacturing processes
• Collaboration with experienced professionals from QA, QC, manufacturing and technical departments
• The opportunity to contribute to the continued development of the Quality Management System
• A professional freelance assignment with a competitive hourly rate, €90 -€100

Interested?
Are you an experienced freelance QA professional who can quickly add value in a dynamic GMP environment? We would be pleased to discuss the assignment and your availability.