A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Compliance Manager to join their UK team. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide.
Role and Responsibilities:
- To conduct a review and analysis of the existing UK and Ireland Affiliate Quality Management System (QMS) to identify areas for process improvement to enhance the organizations compliance maturity
- To develop a project road map of next steps and key initiatives to enhance the Affiliates compliance program
- To lead the identified quality assurance projects and continuous improvement activities within the affiliate across all GxP areas
- Anticipated areas of focus for project delivery include:
- Risk assessment
- 3rd party compliance & oversight
- Testing & monitoring
- Audits & investigations
- Metrics & reporting
- The Project Manager will be required to work within the established and growing Quality & Compliance team to collaborate on delivery
Skills and Requirements:
- Extensive knowledge of the quality management principles and all applicable GxP areas including
- ABPI and IPHA Code of Practice & Healthcare Compliance
- Pharmacovigilance Legislation
- Responsibilities of a Wholesale Dealers Authorisation Holder (GDP)
- Substantial experience in establishing a QMS ideally with experience within a Pharmaceutical company (especially at an affiliate)
- Solution orientated with an ability to lead teams and influence at all levels
- Highly organized and efficient
- Able to multi task whilst maintaining a very high level of accuracy and attention to detail
- Life science/pharmacy degree
- A professional qualification in Quality and/or Process Improvement would be advantageous
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ivan Gitardi on +44 203 0789 551 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.