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.
- 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 firstname.lastname@example.org.
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.