(Sr.) QA Officer
About Pharming Group N.V.
Pharming Group N.V. is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands.
Our Vision
Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets, leveraging proven and efficient clinical development, supply chain, and commercial infrastructure.
Life at Pharming
Today more than ever, we're positioned to realize our vision of becoming a leading global rare disease company. Our success will come from everyone's commitment to our patients, our ability to work with focus and clarity, and our shared dedication to building something meaningful together. We can only achieve this by embracing our biotech culture, Life at Pharming, which is dynamic, experimental, and shaped by what we learn together.
The Role
Quality is at the heart of everything we do. In this role, you will join the Quality Assurance department as a Senior Quality Assurance Officer with a strong background in Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP).
You will act as a subject matter expert for GVP and GCP, ensuring that processes meet the highest regulatory and quality standards. Working in a cross‑functional and collaborative environment, you will partner closely with colleagues across Pharmacovigilance, Clinical Operations, Regulatory Affairs, and other departments, as well as with external partners such as suppliers and vendors.
This role is ideal for someone who is driven by continuous improvement, enjoys collaboration, and has a strong interest in enhancing compliance across clinical and pharmacovigilance activities.
Areas of Responsibility
- Act as a GVP and GCP subject matter expert, providing guidance, coaching, to QA colleagues and cross-functional teams.
- Organize and lead meetings with Pharmacovigilance department to support effective problem resolution.
- Lead and coordinate investigations related to deviations, Change Controls, CAPAs, Risk Assessments, as well as associated reports.
- Review and assess Quality documentation (e.g., PV and clinical related documentation) , ensuring compliance with applicable regulations, guidelines, and internal procedures. Identify, communicate, and drive opportunities for continuous improvement.
- Plan, conduct, and lead GVP and GCP audits (internal, external, vendors, and partners) as Lead Auditor
- Initiate, develop, and implement new or improved Quality processes and procedures within the area of expertise to enhance compliance, efficiency, and quality performance.
- Communicate and negotiate with suppliers regarding deviations, audits, and complex Quality-related projects, ensuring alignment with regulatory requirements and contractual obligations.
- Support regulatory inspection readiness activities, including preparation, hosting, and follow-up of inspections
- Represent the Quality Assurance department in significant and complex cross-functional projects, providing expert QA input and supporting decision-making.
Knowledge
- Bachelor’s degree (BSc) in Biotechnology, Chemistry, Biopharmaceutics, or a related scientific discipline, or equivalent through experience.
- Extensive knowledge of and hands-on experience with EU and U.S. regulatory requirements and quality standards, including GVP and GCP. Case processing experience and knowledge of GLP is considered an advantage.
- Strong understanding of GxP environments and Quality Management Systems within the (bio)pharmaceutical industry.
What you bring
You are a quality-minded professional who combines regulatory knowledge with a pragmatic, collaborative approach. You are confident working with stakeholders at different levels and know how to translate requirements into effective, compliant, and workable processes.
We are looking for someone with:
- A bachelor’s degree in biotechnology, Chemistry, Biopharmaceutics, or a related scientific discipline, or equivalent experience.
- At least six years of experience in a biopharmaceutical or pharmaceutical environment, including a minimum of four years in a dedicated Quality Assurance role.
- Demonstrated knowledge of EU and U.S. regulatory requirements, especially GVP and GCP.
- Strong understanding of GxP environments and Quality Management Systems in the biopharmaceutical industry.
- Experience with SOPs, policies, deviations, CAPAs, change controls, risk assessments, and quality-related reports.
- Experience in planning, conducting, and leading GxP audits,
Preferred Qualifications (Nice-to-Have):
- Experience with case processing and/or GLP.
- Experience supporting regulatory inspections or inspection preparation.
This is an excellent opportunity for someone who enjoys working independently, influencing stakeholders, and bringing practical quality expertise to complex projects in a growing biopharmaceutical environment.
Why join Pharming?
At Pharming, you become part of a growing, science-driven company where patients are at the heart of everything we do. Your work will have a real impact supporting the delivery of safe, high-quality therapies for rare diseases while contributing to a strong culture of quality and compliance.
You will join a collaborative and supportive QA team, known for its approachable and knowledgeable colleagues, where ideas are valued and teamwork is key. We foster an environment where people genuinely enjoy working together and supporting each other.
In addition, we offer:
- A competitive salary
- 30 days of annual leave (calendar year)
- Opportunities to work cross-functionally and influence continuous improvement initiatives
- A caring and inclusive company culture that supports your professional growth
This role offers the opportunity to be part of a company where your knowledge and initiative can make a real impact for both the organization and patients.
Interested?
Join Pharming as our new (Senior) QA Officer and help us continue building a strong culture of quality, compliance, and continuous improvement.