Director, GCP QA (hybrid)

Proclinical are recruiting for a Director, GCP QA to join a biotech organisation. This role is on a permanent basis and is located in London with hybrid working available.

Responsibilities:

• Handle, raise and hose the clinical review board escalation procedure in reply to any recognised crucial/serious quality incidents connected to clinical operations.
• Accountable for guaranteeing that own training and that of the team is assumed before task completion in a compliant and timely manner.
• Assure own KPIs, plans, targets and goals are efficiently tracked, supervised, and completed rendering to timelines.
• You will prepare for, and hose regulatory inspections in GCP needs.
• Offer CQA oversight and follow up on third-party vendor and suppliers' performance such as CROs, CMOs, etc.
• Serve as a QA lead on all clinical quality concerns possibly linking to regulatory proposals, clinical protocols and the performance and reporting of clinical trials.
• Work alongside and assist he pre-clin and clinical senior management and personnel to ensure compliance performance of clinical studies.
• Other duties may be assigned.

Key Skills and Requirements:

• Familiarity in a line management role for a QA Clinical team handling tasks such as auditing and compliance.
• Educated to a degree / advanced degree level in a scientific field.
• Demonstrable experience working in a senior management role within a pharmaceutical/biopharmaceutical quality assurance GCP/GLP function.
• Expertise, comprehension of the implementation of GCP/GLP guidelines as well as with outlining and harmonising quality management systems mixed with a background in successful execution.
• Interpersonal and communication skills both verbally and in writing.
• Capable of forming solid relationships with various individuals.
• Acquaintance with hosting and following up on corporate audits, client audits and regulatory inspections.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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