Clinical Quality Consultant - REMOTE
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Proclinical is seeking a remote Clinical Quality Consultant for a cutting-edge biotech company.
This role will play an important role in ensuring GCP compliance in support of clinical programs and clinical trials. This position will partner with other departments and oversee clinical trial documentation and quality systems.
Prefer someone in the Pacific time zone or the flexibility to be available Pacific time zone hours.
Must be eligible to work in the US.
- Develop and manage the clinical QA audit program for internal processes, investigator sites, vendors and contract service providers to ensure GCP compliance.
- Plan and perform clinical GCP audits and GVP audits; issue audit reports and track responses to closure.
- Ensure quality and compliance issues are addressed and CAPAs are tracked to completion
- Maintain audit and CAPA logs and associated clinical QA documentation.
- Review clinical protocols, reports and other documentation as needed.
- Support development and implementation of Clinical Quality Assurance SOPs; contribute to the development of other related procedures (Clinical, Drug Safety, etc).
- Support GCP QA regulatory Health Authority inspections such as the FDA and EMA, etc.
- Generate and oversee quality metrics and advise management, as appropriate
- Represent CQA in project teams and provide ongoing GCP compliance support.
- Provide GCP training as needed (internal/external).
Skills and Requirements:
- BS in life sciences or equivalent experience
- 8-10 years in pharmaceutical/biotechnology industry, CRO or equivalent experience
- 4+ years direct and relevant clinical quality assurance experience (GCP) - oncology experience is a plus
- Knowledge of FDA GCPs, EMA Regulations and ICH guidelines.
- Prior experience with regulatory inspections and inspection readiness is strongly desired
- Strong written and oral communication skills are required
- Demonstrated experience working with cross-functional teams
- Ability to manage competing priorities and work independently
- Proficiency in the use of relevant computer systems including MS Office.
- Some travel required (approximately 30%)
If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at +(1) 617-830-1627 or email@example.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.