Quality Assurance Manager

QUALITY MANAGER WILTSHIRE AREA 12:MONTH FTC (Competitive Salary)
Blackfield Associates are currently supporting a leading healthcare organisation to recruit for a Quality Manager to join the organisation, initially on a 12:month FTC basis for maternity cover. Flexibility with hybrid working is available (minimum 2 days a week onsite).
Reporting to the Senior Quality Manager, the core function of the role will be to manage a small team of Quality Officers, conducting regular 1:1s and managing the workload within the team. You will be ensuring the supply chain operations comply with all relevant quality legislation (cGMP, cGMP, MDD/MDR, ISO etc.). You will act as Responsible Person or Deputise for the Responsible Person when required. Additionally you will be responsible for:

• Promoting the awareness of the QMS and any applicable regulatory requirements throughout the organisation
• Lading external supplier audit and qualification
• Developing appropriate Quality Technical Agreements with suppliers
• Request, review, process all GMP/GDP documentation
• Manage critical quality issues
• Ensure all change requests are managed according to the QTA
• Assess quality trends
• Manage GMP and GDP inspections by competent authorities and customers
• Implement and maintain Operations SOPs
• Lead Global vendor assurance process
  

To be considered for the role candidates must have prior experience within the Pharmaceutical and/or Medical Devices industry, working within Quality Assurance and have prior team management experience, supervisory experience can be considered. Prior GMP and GDP experience is essential. An RP qualification would be preferred, along with experience working to ISO14971 for Risk Management.
As well as a competitive salary on offer, the role comes with an excellent benefits package and you would be working within a beautifully renovated facility.
In order for this role please forward your CV to or call Melissa on +44 (0) 322 306 for further details.
STR Limited is acting as an Employment Agency in relation to this vacancy.