Sr. QA Officer
About Pharming Group N.V.
Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia-Pacific.
Our Culture
Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.
The role:
The Sr. QA Officer within the QA Systems team plays a crucial role in ensuring that the quality systems within the company are effectively implemented, continually improved, and properly maintained. This position is essential in ensuring that all quality systems meet the required standards and operate efficiently.
- Implement, improve and maintain parts of the Quality Management System.
- Provide sme input on the use of the QMS, making sure it meets the requirements for compliance with current EU and USA pharmaceutical legislation (e.g. GMP, GDP, GCP, Data Privacy, etcetera).
- Key player in application, maintenance and projects related to the QMS.
- Write, implement, review, and maintain SOPs, policies, and other QA related documentation in alignment with applicable GxP guidelines.
- Identify documents which need to be created or updated ensuring optimal GxP compliance.
- Perform internal and external audits, as co- and/or lead auditor, to determine compliance with applicable guidelines (like GMP, GLP, ISO, GDP, GCP, GVP).
- Give general GMP and GDP training to Pharming colleagues.
- Act as trainer and coach for the more junior colleagues regarding the use of quality systems.
Your profile:
Knowledge
- Bachelors or University degree (bio)pharmaceutical sciences, (bio)chemistry or equivalent.
- Extensive knowledge of GMP regulations for EU and US (GMP, GLP and GDP) and the use of quality systems.
- Good knowledge and experience with ERP and QMS systems.
- Preferably knowledge and experience of Project management.
Experience
- Six years of experience in (bio)pharmaceutical environment with at least four years in Quality Assurance.
- At least 4 years experience with the use and improvement of Quality Management Systems.
- Awareness of GxP regulations (EU, US) and US-CFR21 part 11.
What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:
- A highly competitive salary
- 8.33% holiday allowance (for NL)
- A minimum of 30 vacation days
- An excellent pension plan
- Commuting allowance
You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all “Pharmers”.
Also important! We truly value a healthy life-work balance with a lot of flexibility.
Apply for the job
Does this sound like you and do you want to join our team? Then we'd love to hear from you!
We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.