Head of Quality and Regulatory / QA Director

Posted 14 September by Scientific People Ltd
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Director / Head of Quality and Regulatory

Our client, an established contract services company, is seeking to recruit an experienced Quality professional for the role of Director / Head of Quality and Regulatory. The Quality Director will be responsible for the strategic direction and running of the QA and QC departments covering both GXP testing and IMP licensed manufacturing facilities as well as providing strong regulatory advice and strategy, both internally and externally. The successful candidate must have experience in applying EU and US GMP manufacturing regulations as well as being able to demonstrate excellent organisational and leadership skills.

Duties include:

  • Ensuring that GMP, GLP and GCP compliance is maintained throughout our testing facilities and IMP licenced cell bank manufacturing facility.
  • Design, effective implementation and monitoring of the QMS systems to meet the appropriate compliance, user, client, and business requirements.
  • Build a high performance Quality team
  • Responsibility for Head of QC duties as specified in Eudralex, Volume 4
  • Promote and maintain a Quality culture throughout the organisation.
  • Develop a client Regulatory support service

The ideal candidate will be degree qualified in a Life Science subject and have significant quality management experience applying EU and US GXP regulations. The candidate must have demonstrable leadership and motivational skills to create high performance teams. Strong organisational, communication and IT skills are required.

Required skills

  • GLP
  • GMP
  • Quality Assurance
  • Regulatory Affairs
  • GxP

Reference: 36120216

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