(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
The Senior QA Officer will play a critical role in ensuring compliance with Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) across the organization. The Senior QA Officer is responsible for planning and executing audits, writing, implementing, reviewing, and maintaining SOPs, policies, and other Quality Assurance–related documentation in alignment with applicable GxP regulations and guidelines. The role ensures that documentation is complete, current, well‑organized, and fit for regulatory and operational use. The Senior QA Officer proactively acts as a subject matter expert in GVP and GCP, supporting inspection readiness and driving continuous improvement initiatives 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.
Experience
- Minimum of six years of experience within a (bio)pharmaceutical environment.
- At least four years of dedicated experience in Quality Assurance roles, with demonstrated responsibility for compliance, audits, and quality system activities.