Director, QM Development Projects
A multinational pharmaceutical organisation is looking for a dynamic Director of Quality Management Development Projects. This role will include leadership and oversight to the development to ensure compliance.
- Manage GMP quality oversight (qualification, approval, monitoring) of C(D)MOs and suppliers of starting materials by planning and executing vendor audits, including monitoring of CAPA progresses till completion
- Negotiate, establish and maintain quality agreements
- Perform Gate Reviews for PPQ readiness
- Ensure Inspection readiness of all GMP Vendors
- Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to all activities associated to a program
- Manage GMP compliance during Tech Transfer activities by reviewing, approving, as applicable, protocols, plans and reports (e.g. development, validation)
- Identify the risks and establish appropriate mitigation plan
- Responsible to review and approve all GMP documents needed for submission
- Bio similarity data management and Integrity
- Responsible for GMP/GDP quality in FKSBS sponsored clinical studies
Skills and Requirements
- A BA/BS, MA/MS or PhD in a scientific discipline or related field
- Minimum 10 years' experience in a Quality function with increasing levels of responsibility in the biopharmaceutical industry
- Experience with regulatory agencies such as the FDA, EMA, etc.
- Proven success in CMO quality management for clinical products
- Excellent communication skills in English, both written and oral, knowledge of French and/or German is an asset
- Decision Making & Problem Solving
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.