Senior Consultant QA

Senior Consultant QA

Company profile

3D-PharmXchange is a Dutch drug development consultancy and operational support firm located in Tilburg, Oss & Amsterdam. We are dedicated to the development of (bio-) pharmaceuticals such as small molecules, vaccines and ATMP’s. Our team of experts covers the key areas of pre-clinical, clinical, CMC, regulatory affairs, and project management. In addition, we provide out-licensing, interim management support and Quality Assurance services. Our clients are innovative biotech companies, start-ups, academia, and pharma companies.

Job description

As a QA Consultant you will actively supporting our clients in implementing quality systems, managing compliance processes, and driving continuous improvement. Your role will ensure that clients' QA frameworks comply with regulatory requirements while remaining practical and efficient. You will closely collaborate with our QA, CMC, Clinical and Regulatory Affairs consultants, serving as the subject matter expert (SME) for all QA related questions and projects. A key focus will be GMP manufacturing, including reviewing quality documents and guiding clients toward compliance across various stages of development and organizational maturity. You will also join or lead audits at the CDMO’s and CRO’s we work with. Dependent on your experience you may be responsible for setting up and leading our internal QA department. In addition, your role will include oversight of QMS requirements for all disciplines within 3D-PXC.

Minimal requirements

• BSc or MSc degree with experience in the Life Sciences sector
• 10+ years of QA experience in the pharmaceutical or life sciences industry
• Demonstrated knowledge of GMP, GCP, and GLP regulations
• Personality skills : pro-active, team player, solution-oriented, can-do mentality and the ability to put yourself in the position of our clients
• Expertise in QMS implementation, CAPA management, and audits
• A pragmatic, hands-on approach — able to guide clients toward lean and efficient QA systems
• Strong communication and advisory skills, able to translate complex regulations into practical solutions
• Ability to engage with multiple stakeholders, from operational teams to senior management
• Train and mentor client teams on best practices in quality management
• Act as a trusted advisor, ensuring a pragmatic, risk-based approach to compliance

Our offer :

Interested? Send your CV and short motivation letter to Margarida Neves at margarida@3d-pxc.com.

Acquisition is not appreciated!