Your new company

Your new role

• Qualified Person certification and batch release of clinical supplies
• Acts as a Responsible Person on a WDA for Pre-Approval Access
• Support for Health Authority GMP/GDP inspections and audits across the supply chain
• Advise stakeholders on quality issue management and process enhancement/compliance – ensuring consistent quality standards and fostering strong working relationships
• Incorporate global regulatory trends and changes into Supply Chain Quality
• Site master file maintenance

What you'll need to succeed

• Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorisation
• Previous experience as a Responsible Person on a WDA is preferred
• Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
• Proven track record of building/ maintaining high-performance teams/organisations and influencing/ motivating global teams to achieve results
• Proven leadership / influence management skills with the ability to foster partnerships in the matrix organisation across functional/ geographic/ cultural/partner boundaries

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Pawel Jurkiewicz on 0834487062 now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.