ABOUT THIS ROLE
Northreach has partnered with one of the most exiting T-cell Cancer therapy company.
The organisation is moving in Clinical trials and we are looking for a QA Director with experience in setting up the QMS and promote a Quality culture at all the levels.
In this role you will be responsible to design and develop a fully compliant GXP Quality Systems (QMS) to support the transition from R&D to Clinical Manufacturing ph1/2 of ATMP products.
- Setting up a quality system from scratch to meet GxP requirements for CGT products
- Implementing a Quality Mindset and Culture across the entire organisation
- Writing SOP’s and other relevant GxP documents
- Selecting an appropriate QMS, DMS, LMS solutions including tools to manage complaints, CAPA’s, Deviations, change controls and specifications
- Identifying and qualifying external collaborators
- Leading inspections and audits from external parties
- Assuring appropriate oversight of external (GxP) activities, including vendor qualification, contributing on Quality Agreements, performing audits and tracking CAPA follow-ups.
- Responsible for oversight of External CMOs and partners to assure on-time, compliant documentation and batch release.
- Be the lead and Quality representation during any GxP audits/inspections by health authorities.
THE IDEAL CANDIDATE
- Record in setting up Quality Management systems for large molecular products is a must.
- Excellent interpersonal, communication, and presentation skills.
- Cell Therapy experience, Biotech or Biopharma experience
- Strong knowledge of biopharma industry. Familiarity/experience with end to end CMC drug development and clinical Manufacturing.
- Degree in Life Sciences or related discipline.
- Advanced degree in Life Sciences-related discipline strongly preferred.
- Certification / Eligibility as EU QP and qualified GxP auditor required.
- Ability to work cross-functionally, with matrixed teams; maintaining strong business partner relationships.
- Strong leadership skills and executive presence; ability to positively influence outcomes.
- Expertise in conflict resolution.
- Excellent critical thinking and problem-solving skills.
- Willingness to do what needs to be done in a dynamic environment.
- Experience working in global setting.