Templarfox are working with an innovative and fast growing biotech CDMO based in Hertfordshire area, who are looking to appoint a Head of Quality Assurance/ Director of Quality to join their team on a permanent basis. The role will be accountable for the ownership and maintenance of a fully compliant GMP Quality Systems (QMS) to support the manufacturing journey from R&D to Clinical batches of ATMP products.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Head of Quality Assurance/ Director of Quality will be varied however the key duties and responsibilities are as follows:
• Build, develop and foster a quality team covering QA, QC, Regulator Affairs and QPs.
• Continue the development of the PQS to meet GMP requirements for ATMP/VGT products.
• Train and develop a Quality Mindset and Culture across the entire organisation.
• Assuring appropriate oversight of external (GMP) activities, including vendor qualification, contributing on Quality Agreements, performing audits and... tracking CAPA follow-ups.
• Be the lead and Quality representation during any GMP audits/inspections by health authorities.
• Drive interactions on Quality management processes and lead the technical teams in all Quality relevant topics with industrial customer clients in development and manufacturing.
• Give guidance in preparing and submitting variations and market authorisation applications at different regulatory authorities.
ROLE REQUIREMENTS:
To be successful in your application to this opportunity as the Head of Quality Assurance/ Director of Quality
• Masters/Diploma degree or Doctoral degree (PhD) in virology/biologics, biotechnology, pharmacy, or equivalent
• Previous experience of managing a Quality Management systems PQS for ATMPs or large molecular products.
• With ideally minimum 3 years in a quality leadership role in the field of ATMPs or Cell Therapy experience, Biotech or Biopharma experience
• Proven leadership with Excellent interpersonal, communication, conflict resolution and presentation skills.
• Ideally qualified GMP auditor and successful interaction with regulatory bodies like MHRA.
• Ability to work cross-functionally, with matrixed teams; maintaining strong business partner relationships.
• Proven experience building, managing people and developing skills and employee engagement.
If you believe you hold the relevant background experience and looking for a new role as Head of Quality Assurance/ Director of Quality within successful and growing CDMO business then this is the role for you.
About us: Templarfox is a privately owned recruitment business leading in executive search, management selection, Salary benchmarking and Business development services. The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency
London UK

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