Senior QA Officer

Help ensure life-changing therapies reach patients safely and compliantly

Are you an experienced Quality Assurance professional with a strong background in GMP-regulated environments? Do you enjoy working at the heart of product quality, batch disposition, and quality oversight while collaborating with internal teams and external partners? If so, we would love to hear from you.

About Pharming

Pharming is a global biotechnology company dedicated to developing innovative therapies for people living with rare diseases. Our mission is to improve patients' lives by addressing significant unmet medical needs. Quality, collaboration, and innovation are at the heart of everything we do.

Your work environment

As a Senior QA Officer, you will be part of the Quality Assurance team within Pharming Technologies B.V. in Leiden. In this role, you will play a key part in ensuring the compliant release of clinical and commercial products while supporting product quality oversight and GMP compliance across manufacturing operations. You will work closely with Manufacturing, Quality Control and Supply Chain teams to support reliable product release while ensuring compliance with applicable EU and US GMP requirements and Pharming quality standards.

A key focus of the role is supporting the batch release process by reviewing and assessing product documentation, identifying potential quality risks, and preparing quality assessments that support Qualified Person (QP) release decisions. You will work closely with colleagues in Manufacturing, Quality Control, Regulatory Affairs, Supply Chain, and external partners such as contract manufacturers, laboratories, and suppliers.

What will you do?

• Review, assess and prepare QA release packages for clinical and commercial batches, ensuring complete and compliant documentation to support Qualified Person (QP) disposition and release decisions;
• Provide QA oversight on deviations, investigations, CAPAs, change controls, and risk assessments, driving effective and compliant resolution of quality issues;
• Author, review, approve, and maintain GMP documentation, including SOPs, quality agreements, protocols, reports, and other quality system documents;
• Act as the key QA contact for external manufacturers, laboratories, suppliers, and service providers, ensuring alignment with Pharming's quality standards and regulatory requirements;
• Plan and perform internal and external audits, support supplier qualification activities, and contribute to inspection readiness and regulatory inspections;
• Coach colleagues on GMP and quality best practices while driving continuous improvement initiatives to strengthen the Pharmaceutical Quality System and quality culture.

What do you bring?

• A Bachelor's or Master's degree in Biotechnology, Pharmacy, Chemistry, Biopharmaceutical Sciences, Life Sciences, or a related discipline, combined with at least 6 years of experience in the pharmaceutical or biopharmaceutical industry, including 4+ years in Quality Assurance;
• Strong knowledge of EU and US GMP requirements, with experience in quality systems, batch documentation review, investigations, CAPAs, change control, risk management, and eQMS platforms;
• Experience conducting internal and external audits, working with CMOs, suppliers, and other external quality partners in a regulated environment;
• Excellent communication and stakeholder management skills, with the ability to provide clear quality guidance, influence decision-making, and build strong working relationships across functions;
• A structured, proactive, and quality-focused mindset, combined with fluency in English and willingness to travel internationally for audits and supplier oversight activities.

What can you expect from us?

• A challenging role within an innovative international biotechnology company.
• The opportunity to contribute directly to the development of therapies for patients with rare diseases.
• A competitive salary ranging from €60,000 to €80,000 gross per year, including 8.33% holiday allowance (based on a full-time position);
• 30 vacation days per year (based on a full-time position);
• An excellent pension plan;
• Opportunities for personal and professional growth;
• A collaborative, purpose-driven environment where your work helps bring innovative therapies to patients around the world.

Interested?

Are you excited about this opportunity and do you recognize yourself in this profile? We look forward to receiving your application.

Please note: Due to the holiday period, applications will be reviewed from mid-August onwards. We appreciate your interest and will contact you as soon as possible regarding the next steps in the recruitment process.