Clinical QA Manager
Jim Gleeson is recruiting for a Clinical QA Operations Senior Manager to join an innovative and highly successful biotechnology developing novel treatments for neurological disorders. The role will be based at their site in Cambridge.
As Clinical QA Operations Senior Manager you have overall QA responsibility for a product in development, leading a team of auditors assigned on a per project basis.
Key Duties will include:
- Supporting the company's risk based Quality Management System from design, implementation and execution through life cycle management.
- Contribution to the planning and execution of all audit schedules, covering internal, Vendor, clinical investigational sites and pharmacovigilance activities.
- Resource and management of CQA professionals to meet the needs of relevant audit programmes.
- Provision of GCP, GLP and regulatory advice to Program and Clinical Study Teams.
- Ensuring that direct reports are appropriately trained and have Personal Development Plans in line with departmental goals.
As Clinical QA Operations Senior Manager you will require the following:
- A relevant BSc.
- Extensive GCP experience gained in a pharmaceutical company or CRO.- A background in GCLP or GPvP would be advantageous.
- Experience of preparing for and hosting regulatory authority inspections.
- Strong interpersonal and communication skills.
For more information or to apply for this position, please contact Jim Gleeson on 01438 870027 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 46600 in all correspondence.