AX-7125 Senior QA Manager
Leading global healthcare & diagnostics company require an experienced QA professional with for this key role managing site quality systems in line with local, national, international regulatory requirements
Leading global healthcare & diagnostics company
Role has 5 direct reports
Excellent career development opportunities
- Assure compliance with necessary local, national, international regulated and non-regulated products and services requirements through the Quality Management System including continuous improvement, CAPA management, quality planning, internal and external audits, supplier quality, validation, risk management, complaint investigations, quality control activities and continuous Quality Management Review.
- Responsible for product transfers from R&D site to the UK for testing.
- Escalation point of contact for quality related incidents.
- Control all incoming raw materials to the site, looking after the manufacture and release of the final product.
- Acts as management representative during compliance inspections.
- Position is also responsible for negotiating with external regulatory agencies to ensure the continuing suitability, adequacy and effectiveness of company’s Quality System.
QUALIFICATIONS / EXPERIENCE REQUIRED:
- BS degree (Advance Degree preferred but not required) in biological sciences, life sciences or related discipline
- Significant QA experience in the in vitro diagnostics, medical device or pharmaceutical industries; in a wide breath of Quality Assurance or Regulatory roles
- Plant management experience
- Must have strong understanding of applicable Quality System Regulations and ISO / FDA quality requirements.
- Ability to plan and/or oversee quality system/processes, documents, and vendor audits/assessments
- Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
- Team management experience
- Ability to manage multiple projects.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300. To apply, please click APPLY ONLINE.
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AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market.