Michael Page Switzerland

QA Manager GCP/GLP m/f

22 November | Executive po­si­tion | 100%

As QA Manager GCP/GLP m/f, you will ensure quality and compliance of sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific, and current industry standards and practices) as well as support the non-clinical team on ensuring GLP studies are conducted in a compliant manner.

QA Manager GCP/GLP m/f

Our client is a bio-pharmaceutical start-up specialised on immune diseases, based in Geneva.

Description

Quality system:
- Maintaining the Quality System,
- Maintaining Clinical SOPs and other quality documents,
- Maintaining the SOP training matrix and verifying that staff (including consultants) carry-out the required training on SOPs and GCP,
- Setting-up, running and writing meeting minutes/following-up on Annual Quality Meetings,
- Expert being available to answer quality questions from staff and vendors as required (e.g. GCP),
- Schedules and/or delivers yearly GCP training for internal staff.

QA expert advice:
- Assisting in investigations of potential breaches of GxP, and in the subsequent CAPA,
- Provide GCP and GLP QA oversight and support to internal staff,
- Contributing to the quality aspects of vendor selection activities (e.g. review of quality questionnaires and responses, review of suppliers audit reports etc.),
- Contributing/Reviewing key study documents (e.g. IB, protocol, ICF, CSR) as QA expert,

Profile

Bachelor's/Master's Degree in a scientific discipline, a combination of relevant education and applicable job experience may be considered.

* Minimum of 8 years in the Pharmaceutical industry with 5 years in GCP QA;

* Solid understanding of GCP, GLP and ICH clinical requirements

* Experience with international clinical studies

* Experience with Biotech company will be a plus

Job Offer

Permanent part-time position (50-60%). CV to be send in PDF format.