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Associate Director Quality Assurance CMC

Headquartered in Nijmegen, The Netherlands, Tagworks Pharmaceuticals is a dynamic biotech company with strong backing from prominent US and European investors. Specializing in proprietary in vivo click chemistry, Tagworks is committed to improving the effectiveness and reducing the toxicity of systemic cancer treatments. Operating at the Radboud University Medical Center, Tagworks pioneers unique approaches towards antibody-drug conjugates (ADCs), prodrugs, and targeted radiotherapeutics through its "Click-to-Release'' platform, rooted in Nobel Prize-winning research. To further strengthen the organization, we are looking for a Associate Director Quality Assurance CMC.

The position
Our Associate Director of Quality Assurance CMC will provide leadership and hands-on operational execution in the establishment, implementation and maintenance of a phase-appropriate and continuously evolving Quality Management System (QMS). You have a background in supporting the development of clinical stage products including GCP, GMP, GVP and other relevant GxP. You are able to employ a pragmatic, fit-for-purpose approach and are capable of building and maintaining a phase-appropriate quality structure to support external CMC operations, including the establishment and adherence to vendor Quality Agreements. You oversee all quality aspects of product development, including scale-up, process improvement, technology transfer and process validation activities, ensuring CMO compliance with all applicable cGMP regulations, batch records, validated processes, QC testing and data integrity. Your responsibilities include the review of technical data including executed batch records and all related documentation. You collaborate with other subject matter experts to support CMOs in QA related investigations and analytical issues. You will identify any training requirements necessary to meet the quality standards and ensure completion of such training.

The requirements
We expect our Associate Director Quality Assurance to

  • Have a BSc or MSc degree in a relevant scientific discipline or equivalent experience.
  • Bring 10+ years of experience in quality assurance roles within the pharmaceutical or biotechnology industry, covering both small and large molecules.
  • Have experience in working with external parties, such as CMOs and contract labs.• Have in-depth understanding of GxP principles, concepts, practices and standards.
  • Bring comprehensive knowledge of GCP, GLP and GMP standards for clinical stages including US and EU requirements.• Have proven ability to establish and manage quality systems in small companies.
  • Have experience in performing Quality audits of external vendors.
  • Have the willingness to travel to CMOs and vendors to audit and oversee cGMP/GLP compliance.
  • Be accustomed to “roll up their sleeves” and executing tasks as needed in a small company environment.
  • Bring experience with ADCs, which would be a plus.You are a team player who can collaborate and work successfully with multiple key stakeholders. You have strong verbal and written communication skills.

You are a highly motivated, resourceful individual who can set goals, shift priorities, work independently and collaborate effectively with project teams. Finally, you have good organizational skills and attention to detail.

The offer
You will join a group of passionate and very skilled professionals working towards a common goal. We offer a set of attractive and competitive benefits, recognizing and rewarding our talented and motivated employees.    

Our culture and values
At Tagworks, our culture is built on innovation, collaboration, inclusivity and achieving results. We prioritize teamwork, flexibility, resilience, adaptability, and fulfilling commitments. 

How to apply
Please send your CV together with a cover letter to hr@tagworkspharma.com

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Contact
T +31 85 800 8550
info@tagworkspharma.com

Address
Tagworks Pharmaceuticals BV
Toernooiveld 1
6525 ED  Nijmegen
The Netherlands

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