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Job Details

Quality Director

Company: X4 Group
Location: Oxfordshire
Reference: MWQADOX
Closing Date: 14 Mar 17
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

Job Vacancy: Quality Director/ QA Director Location: Oxfordshire Salary: £70,000- £80,000 per annum (depending on experience)A Pharmaceutical Company based in Oxfordshire are currently looking for a Quality Director to join their team on a permanent basis.The Quality Director will represent Global Quality Assurance supporting the clinical pipeline with a primary focus on European contract manufacturing and development activities. ...

Requirements:

Job Vacancy: Quality Director/ QA Director

 

Location: Oxfordshire

 

Salary: £70,000- £80,000 per annum (depending on experience)

A Pharmaceutical Company based in Oxfordshire are currently looking for a Quality Director to join their team on a permanent basis.

The Quality Director will represent Global Quality Assurance supporting the clinical pipeline with a primary focus on European contract manufacturing and development activities.

This position will provide Quality Assurance oversight for current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP). 

The scope of the position includes establishment of an integrated quality system inclusive of validation, change control, CAPA, documentation management, and compliance. 

Quality Director: Key Responsibilities:

  • Provide senior level cGMP expertise and oversight for regulatory compliance.   
  • Primary point of contact in for the Electronic Quality Management System management.
  • Lot release, documentation process flows, quality risk management and internal and external auditing processes. 
  • Provide final Quality approval of all documentation (SOPs, Protocols, Reports, etc.) supporting GMP or GLP operations as required.
  • Oversee and monitor Quality standards as required with particular focus on development and technology transfer.  Responsible for establishment of procedural framework for identifying, collecting, distributing and filing controlled documents supporting manufacturing, development, technology transfer, and GLP laboratories
  • Responsible for defining the appropriate level of training required for several Quality Management System processes in and collaboration with the training manager to ensure requirements are implemented.

Quality Director- Skills and Experience:

  • Degree in science or engineering, advanced degree preferred.
  • Must have significant experience in managing a quality function including direct experience supporting development and technology transfer activities.
  • Proven track record managing quality functions for a small, growing company.
  • Superior knowledge of regulatory compliance for autologous therapies, lot release, and quality systems.
  • Biologics, Vaccines, or Sterile Drug Product manufacture.
  • Developing and performing GMP training

If you believe you have the relevant skills and experience for the position, please send me an updated version of your CV to m.wisdom@x4group.co.uk or call Matthew from X4 Group on 020 7812 7700.

Key Words: QA/ Quality Assurance/ Qualified Person/ QP/ Technology Transfer/ RA / Regulatory Affairs

Apply for this job: Quality Director

Contact Information:

Address:  Head Office
2nd Floor, Brettenham House
Lancaster Place,
London,
WC2E 7EN
England
Tel:  02078127700
Website:  Visit Our Web Site

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