Head of Site Quality

Location: Midlands

Salary: £100,000-£120,000

Contract Type: Permanent

AssureBio has exclusively partnered with a pharmaceutical business to recruit a new Head of Site Quality.

This is a unique role that will require an individual to lead the way in assuring high quality standards across the organisation. From overseeing an essential aseptic manufacturing facility to developing strategic visions and delivery plans for the commissioning of a new facility, you’ll have the opportunity to make a profound impact in this pivotal role.

Key Responsibilities

  • Oversee all areas of the company’s Compounding Unit facilities.
  • To help in reviewing, developing, and implementing a strategic vision and delivery plan for the compounding unit’s services throughout the business.
  • Provide professional leadership and supervision of staff in the compounding unit to ensure that the highest aseptic compounding standards are met.
  • To critically evaluate the Quality Systems across all areas to ensure that best practice is promoted.
  • To maintain a document control system as part of the Quality System, in line with GMP and MHRA requirements.
  • To provide documented evidence/reports to demonstrate that the Quality System is performing to the required standards.
  • To manage the commissioning and validation of new pharmaceutical Manufacturing/QC facilities and equipment
  • To approve Technical Agreements made with external contractors for the (re)validation of equipment, facilities, and processes.
  • Lead and explore commercial opportunities for the manufacture of IMPs ensuring a balance between direct patient-care services to company and commercial activities.
  • Develop appropriate business management tools for IMP manufacturing operations.

Essential requirements

  • Proven Quality leadership experience
  • Experience leading a site compliance improvement plan
  • Direct experience of leading regulatory audits (MHRA)
  • Evidence of fostering working relationships with regulatory bodies
  • Aseptic manufacturing expertise
  • Experience supporting new facility builds (GMP)
  • QP eligibility desirable

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