Global Quality Auditor

Job title : Global Quality Auditor
Location : France
Job type : Permanent
Salary : bonus, benefits, remote working
Contact name : John Spring
Contact number : +41 (0) 44 5803 717
Contact email : john.spring@seclifesciences.com
Global Quality Auditor - Pharmaceuticals

This is a fantastic opportunity to join one of the world's leading pharmaceutical companies in a key role that will ensure GxP compliance across a global network of manufacturing and distribution sites. This role plays a vital role in improving the level of quality of products being provided to patients worldwide to treat a variety of medical conditions. This role can be based remotely anywhere in France, Ireland, Netherlands, Poland or Czechia.

Salary & Benefits:

Up to €100k + bonus, benefits and remote working. Full details on request

Role and responsibilities:

*Lead the entire corporate quality GxP compliance audit programme for the assigned region/network
*Leadership and organisation of the company technical audit committee
*Maintain inspection readiness state for all applicable sites (10-15 in your network)
*Corporate Audits - maintain compliance with applicable ISO standards, GxP standards and local and global regulatory body regulations
*Risk Management - ensure best practice and risk assessments take place regularly and ensure quality management systems are compliant
*Hands on auditing will be required in this position, internationally and up to 40% of the time.
*Assist in inspection readiness preparations - external bodies include, but not limited to, FDA, EMA, MHRA, CFDA, Health Canada, ANVISA
*Manage audit reporting and follow ups and introduce continuous improvement and quality culture within the organisation where necessary


Requires skills and qualifications:

*Bachelor's degree or higher in microbiology, biochemistry or similar field
*8+ years' experience within the highly regulated pharmaceutical/biotechnology manufacturing industry
*3+ years' experience as a Lead Auditor
*Excellent hands-on technical QA knowledge (quality systems, CAPAs, change control etc.) and also risk management
*Thorough and up to date knowledge of FDA guidelines and cGMP regulations
*Aseptic manufacturing knowledge a plus, as with medical devices and MDR knowledge
*Ability to travel globally up to 40% of the time
*Mindset to work successfully in a remote work setting


To apply for this position and put yourself under immediate consideration, send your CV to john.spring@seclifesciences.com or call +44 (0) 207 255 6650