Quality Manager, Technical Research Development
An exciting opportunity has arisen for a Quality Manager to oversee Technical Research Development in Switzerland. In this role you will be expected to manage projects and processes to meet timelines and standards. You will support early phase projects or support more complex projects with mentoring.
- Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility.
- Write, review, decide on approval and/or release of GMP-relevant deliverables and or/ related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
- Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
- Support Project management functions as a project team member.
- Provide support to TRD line functions in GMP related topics as per area of responsibility.
- Comply with internal and external guidelines regarding quality and safety
Skills and Requirements
- Good knowledge of cGMP, working knowledge in technical development, production or QA. Good knowledge in the CGT space.
- Sound scientific, technical and regulatory knowledge.
- Good organisational and decision-making skills.
- Good and proven ability to analyse and evaluate cGMP compliance.
- Fluent English required (oral & written). Good skills in site (local) language desired (oral).
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.