|Job title :||Senior QA Manager - GCP|
|Job type :||Permanent|
|Contact name :||John Spring|
|Contact number :||+44 (0) 207 255 6650|
|Contact email :||email@example.com|
A fantastic opportunity to join a fast growing company with international backing and an outstanding pipeline full of innovative, exciting and pioneering drug products across a number of therapeutic areas. If you are a highly experienced Senior Manager within Clinical QA, this will be an ideal position to help you grow in your career and experience global operations.
Salary & Benefits:
Excellent salary and benefits, full details available on application.
Role and responsibilities:
*Working towards the global strategy of the clinical audit programme including site, vendor and process
*Audit management; planning, performing and reporting
*Lead and follow up on regulatory inspections from global authorities
*Manage the CAPA process
*Escalate non-compliance and serious issues
*Manage the documents relating to the quality management system, ensuring compliance with ICH-GCP guidelines
*Manage process improvement process
*Work in close collaboration with internal teams and external partners - CROs etc.
Requires skills and qualifications:
*Minimum 5 years' experience in pharmaceuticals, 3 years of which to be spent within a GCP QA auditing environment
*Life Sciences degree - Bachelor or Master degree
*25% worldwide travel
*Fluency in English (written and oral)
*Excellent knowledge of ICH-GCP requirements
*Problem solving mentality, excellent project management and risk management
This is an opportunity to grow within a company that is going to experience enormous growth in the near future. With products ready to commercialise and others in development, coupled with a world class R&D facility and huge financial backing, the possibilities to develop your career are endless.
To apply for this position and put yourself under immediate consideration, send your CV to firstname.lastname@example.org or call +44 (0) 207 255 6600