Global Quality Manager & Affiliate Coordinator - (Europe)
Sam Whyley-Smith at CK Clinical is recruiting for a Global Quality Manager Affiliate Co-ordinator to join a Global Pharmaceutical Company based in the South East of the UK.
Our client is a Global Mid-Sized Pharmaceutical Company with a sole focus on the development and commercialisation of innovative products for the treatment of mental health, endocrinology, nephrology and oncology conditions.
Reporting to the Global Lead of Quality Operations, the Global Quality Manager & Affiliate Coordinator will lead the coordination of Quality Managers across Global Quality to ensure the following:
- Consistent training and information awareness of the Quality Managers in HQ.
- Coordinate the local and Global SOP Administrators engagement and alignment (Project Management)
- Participate in Audits of HQ and other company entities.
- Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees with regards to related findings
- Ensure continuous improvement and enhancement of the Quality Management System by supporting global metrics generation and 'lessons learned from audit/ inspection'
- Contribute to driving Local SOP (LSOP) alignment to Global SOPs and retirement of LSOPs.
- Manage Related planned and unplanned deviations and support by resolving the deviations.
- Drive training curriculum for Quality managers
- Develop and support global compliance training procedures in collaboration with other companies and provide training in the area of expertise as assigned.
- Responsible for maintenance of the Collaboration Portal and e- newsletter
- Communication across information and drive enhancement
- Work Closely with Global Quality Coordinator to drive the Global Activities
- Support the preparation for GxP inspections and responses to Regulatory Authorities
- Follow-up on the development, implementation and completion of corrective and preventive actions with the inspected Functional Areas
- Maintain an overview over the relevant regulatory requirements and state-of the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of procedures.
- Evaluate impact of regulatory changes for the Quality Management System
- Maintain the Quality Management System in an compliant state with a changing regulatory environment
- Be accountable for quality-related input in decision making processes with relevance for GxP compliance
- Act as quality liaison for assigned projects. Provide sound advice and interpretations related to current GxP guidelines and regulations to Senior Management and employees
- Degree in natural science or equivalent number of years experience
Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance, Good Manufacturing Practice or Clinical Development or Computer System Validation
Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the above GxP areas including IMP management and Regulatory Affairs and
- Experience in Monitoring, Quality Assurance and/or Good Clinical Practices
- Exposure to audits & inspection (Qualification as an auditor preferred)
- Understanding of change management processes
- Well versed with MS Office (advance users in Excel & PowerPoint preferred)
- Excellent communication skills (written and oral) in English
- Problem solving and resolution skills
- Analytical and creative thinking
For more information or to apply for this position, please contact Sam Whyley-Smith on 01246 580040 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45940 in all correspondence.