Manager/Senior Manager GCP Quality Assurance (remote)

Proclinical are recruiting for a Manager/Senior Manager GCP Quality Assurance to join a biotech organisation. This role is on a permanent basis with the ability to work remotely from anywhere in Europe.

Responsibilities:

• Execute risk management methods to recognise and mitigate possible quality compliance risks within clinical operations.
• Serve as a representative of QA on both the clinical and non-clinical teams as well as offer compliance advice and leadership.
• Supervise the development, execution and upkeep of a solid QMS for clinical trials, guaranteeing compliance with suitable guidelines and standards.
• Responsible for planning, implementing and handling both internal and external audits of clinical trial actions, which involves vendors and clinical sites, assuring adherence to regulatory needs and company standards.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to a degree level in a pertinent scientific field.
• Demonstrable experience within clinical quality assurance in a biotech or pharma environment.
• Demonstrable experience in GCP auditing which involves vendors, internal procedures, documents and clinical investigator sites.
• Expertise on international regulatory standards and affiliated regulations.
• Interpersonal and communication skills both verbally and in writing.
• Works well with others in diverse functional areas.
• Fluency in the English language.
• Enjoy working within start-up companies and takes a practical approach to workload.

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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