SciPro are currently recruiting a new Clinical Compliance Director to support the extensive number of clinical studies currently being undertaken by this international biotech who is looking to support patients with unmet orphan diseases.
If you are an experienced QA professional will have an extensive knowledge of GCP Requirements in particular late phase multi-site study complexities for compliance, covering cGMP of IMP distribution as well as GCP this would be an ideal role. They are looking for a pragmatic approach to risk management and be enthused about the challenge to create a new division within the group.
Key Responsibilities include:
- Ensure oversight of the conduct of Clinical Studies conducted in the E.U. and U.K. comply with EU/UK regulatory requirements (discharge of Legal Representative accountabilities
- Acts as a central point of contact for U.S. affiliates for all Clin Studies-related matters in EMEA
- Develop a Quality framework that operates across all BridgeBio Affiliates to ensure GCP/GMP and P.V. compliance in conjunction with affiliate Q.A. leads
- Ensure inspection readiness framework across the portfolio is consistently applied to all programs
- Lead pre-inspection activities in the EMEA region to support affiliate Q.A. and study teams
- Develop a compliance framework covering assigned CROs and internal clinical study teams
- Advice on sponsor contracting and accountabilities
The role is looking to have the candidate based in Europe offers fully remote working and is looking to offer a salary up €150'000 including benefits. If you are interested in applying please contact John Morkus on 02039295856.