Director, Clinical QA

Found in: beBee S US - 2 weeks ago

San Francisco, United States Proclinical Full time

Proclinical are recruiting for a Director, Clinical QA (GCP) to join a biotech organisation. This role is on a permanent basis and is located in the Bay Area.

Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.

Responsibilities:

Monitor the CQA Systems, which involves leading improvement projects.Offer aid and knowledge on GCP/Pharmacovigilance (PV) related regulatory inspections which involves 'Inspection Readiness' and preparation.Responsible for developing and overseeing the GCP/PV connected annual and project audit schedules.Supervise the international audit programme encompassing GCP/PV related internal, vendor and investigator site audits.Produce and monitor quality metrics and advise management, as suitable.Serve as a representative for CQA in allocated projects and cross-functional groups to offer help and compliance for ongoing and planned clinical trials and initiatives.Other duties may be assigned.

Key Skills and Requirements:

Educated to a degree level in a life science field or similar.A background in quality assurance such as GCP within oncology studies.Demonstrable experience working in a biotech organisation would be ideal.Expertise on clinical processes and procedures, electronic document systems, GCP and affiliated guidelines.Familiarity with preparing for and hosting regulatory inspections.Acquaintance with GCP auditing.Interpersonal and communication skills both verbally and in writing.Prior involvement with European guidelines as well as pharmacovigilance QA is desirable.

If you are having difficulty in applying or if you have any questions, please contact Joshua 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.

#QACompliance

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