Clinical Development Quality Manager
A global biopharmaceutical organisation is currently hiring a Clinical Development Quality Manager to join their team. The organisation is focused on the development of prescription drugs that target unmet medical needs. This is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Acting as GCP expert for the Clinical Development department of DPI and actively support the development of appropriate clinical development processes, systems and tools to ensure compliance with GCP.
- Developing and maintain the Clinical Development Quality Systems and related SOPs in compliance with the laws and regulations governing GCP and the applicable guidelines for the pre-marketing pharmacovigilance (PV) activities.
- Promoting the Quality Culture and actively collaborate to the GxP training activities through the company's development organisation.
- Developing and maintain Quality Agreements with Contract Research Organisations/Vendors and ensure proper review of Vendors agreements to ensure compliance with Good Clinical Practices (GCP).
- Ensuring the appropriate training of concerned collaborators involved in GCP activities through the oversight of the DPI training management system (Ennov Training) and the setting-up/delivery of specific training sessions on clinical quality subjects, new/revised processes, regulations/guidelines, company improvement initiatives, as needed.
- Performing or coordinating the conduct of external audits of investigational sites and Contract Research Organisations/Vendors to verify their compliance with GCP and/or GVP, review and follow-up or related CAPAs. Communicate to Management the CAPAs monitoring and related improvements.
- Setting up the internal clinical development system audits plan and perform or coordinate the relevant internal audits and for cause audits, support the establishment of the CAPAs and ensure regular follow-up of CAPAs with the internal auditees.
- Communicating to Management the CAPAs monitoring and related improvements.
- In collaboration with concerned functions, coordinating the preparation and assist in hosting external GCP audits of DPI (e.g. DPI's partners) as well as of regulatory inspections of DPI, investigational sites, vendors and partners.
- Following-up until resolution on all Corrective and Preventive action plans associated with clinical and pharmacovigilance activities resulting from any source (e.g. deviations, audits and inspections, improvement suggestions).
- Tracking and monitoring the Quality Events (Deviations, Change Controls, CAPAs and other events) and communicating to Management the monitoring trends and related improvements in line with the applicable regulations/guidelines.
Skills and Requirements:
- University degree (for instance Master's degree or Ph.D. in a biomedical subject, nursing degree, etc.)
- 10 years of experience in Quality Management including involvement in managing clinical Quality Management system and compliance audits & inspections, CAPAs.
- Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites and CSR).
- Excellent knowledge of GCP.
- Experience in setting and updating clinical quality SOP's.
- Experience in the mechanism of multiple QA vendors oversight.
- Knowledge of computerised systems validation.
- Rigor, flexibility, adaptability and organisation.
- Pragmatism focused on efficiency and continuous improvement.
- Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities.
- Fluent in English. French is an asset.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Patrick Franke at +44 02074400632 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.