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Job

Quality Assurance Director

  • Location

    Unknown

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Luisa Namadila

  • Contact email:

    l.namadila@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    22 days ago

  • Expiry date:

    2021-08-07

A leading non-opioid pharmaceutical company based in the Wiltshire county are looking to welcome a QA Director on a perm basis. 

Main responsibilty for this role will be the quality oversight of the company's CMOs of which the position holder will be required to be on site full time (flexible working hours available). This is a standalone position of which you will be the main QA professional on site.

Other responsibilities include but are not limited to:

• Assure that all operations performed by CMOs are in compliance with cGxPs and applicable FDA, MHRA, EMA and other international regulations.
• Perform Quality functions 
• Work closely with US QA team, keeping them informed of Exparel manufacturing issues at CMO.
• Work closely with UK team to provide Quality guidance and leadership.
• Review and approve CMO deviations to ensure they meet standards and appropriate CAPAs are identified.
• Review and approve CMO and UK Change Controls and validation reports.
• Ensure CMO compliance with QTA and QTAs are up to date.
• Ensure APQR written by CMO is accurate and completed on time.
• Partner with CMO leadership to improve GMP compliance and ensures KPIs are tracked and trended.
• Provide guidance to CMO in all matters relating to product quality, disposition and release of materials and product.
• Partner with Regulatory Affairs in preparation of filings and submissions, as well as prepare responses to agency requests for information.
• As needed, perform external GxP audits of suppliers/CMO.
• Other responsibilities as required.

Successful candidate will have:

  • Experience in managing CMOs
  • Minimum of 10 years in GMP QA pharmaceuticals 
  • Solution orientated and be ready for a challenge 
  • Aseptic and Sterile experience is a must

Attach an updated CV to be considered 

Please note that VISA sponsorship is not available