Director of Quality - GCP

Hobson Prior are currently looking for a Director of Quality - GCP to join a fantastic biotech organisation on a permanent basis located in London. Our client is focused on producing solutions that may have the possibility of curing those who are suffering from serious illnesses.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will handle, raise and hose the clinical review escalation procedure in response to any recognised crucial/serious incidents linked to clinical operations.
• Accountable for the QMS system, guaranteeing that its fully deployed, kept up to date and upheld in a state of compliance.
• Serve as a QA lead on all clinical quality matters connecting possible to regulatory proposals, clinical protocols, and the performance and documentation of clinical trials.
• Partake in the selection of and current auditing of crucial providers, vendors, CROs and CMOs.
• You will offer CQA oversight and follow up on third party supplier and vendors such as CRO's. CMO's, etc. performance.
• Guarantee that there is a system in place to assist and/or implementation of audits such as site, vendor, process, systems, regulatory proposals, clinical trial papers, etc.
• Cooperate and assist in pre-clinical and clinical senior management and personnel to ensure compliant conduct of clinical studies.
• Any other assigned duties.
• Requirements:
• Educated to a degree level in a science discipline.
• At least 10 years of experience operating at a senior management level within a pharmaceutical/biopharmaceutical quality assurance commercial and GCP function ideally with sterile products.
• Know-how, comprehension and implementation of GCP and GMP guidelines with familiarity with outlining and harmonising QMS incorporated with demonstrated ability of successfully executing these.
• Interpersonal abilities.
• Past involvement in hosting and following up on business audits, client audits and regulatory inspections.
• Know-how and comprehension of pharmaceutical QA and GCP expertise in a clinical trials and operations setting.
• Knowledge of executing QMS which are simple, solid and in compliance with suitable GxP guidelines and regulations.
• Know-how and acquaintance with auditing needs such as lead auditor GCP.
• Conscious of preclinical quality standards and good practices for research.
• Experience working with or within CRO establishments.
• Capable of comprehending multifaceted and current crucial discoveries.
• A practical approach and familiarity with forming a "quality outlook" for team members who have not worked within a GxP setting.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.