Head of Quality and Regulatory – Reading, Hybrid

This Head of QA/RA role will form a key part of the SLT team for a SME business involved in Medical Devices, Cosmetics, and more. Primary aims are implementation of a 9001 QMS, and continued regulatory support.

This UK based SME has a wide portfolio of Medical Devices, Cosmetics, and some Pharma related products. With multi site presence, they are looking for an experience QA leader to join their leadership team. This is a business sub 100 headcount, with ambitious growth plans.

Description

• Oversight of compliance, and responsibility for all QA operations
• Key project for ISO 9001 QMS set up, and continuous improvement
• Coach and mentor colleagues on QMS
• Regulatory affairs is outsourced, but this role retains internal accountability for regulatory oversight
• Cross functional work across Procurement, NPD, Commercial, and others

Profile

Applicants will require the following:

• Proven experience building a risk based and commercially viable ISO 9001 QMS
• Career history at leadership level within Pharma, Medical Device, or Cosmetics
• Familiarity with a smaller business size, ideally reporting to C suite or Directorship

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