GCP Director, Quality Assurance
Posted on :
27-10-2022
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Job Description
Director, Quality Assurance
Location: San Diego, CA
Industry: Pharmaceutical / Biotech
Summary:
Responsible for all aspects of GCP compliance, including inspection readiness. Establish and execute quality plans, policies and quality system elements related to GCP activities. This position will support the design, implementation and maintenance of QA and compliance programs including, but not limited to, an SOP system, CAPAs, site and vendor audits and work closely with the Clinical Operations team.
Responsibilities:
Location: San Diego, CA
Industry: Pharmaceutical / Biotech
Summary:
Responsible for all aspects of GCP compliance, including inspection readiness. Establish and execute quality plans, policies and quality system elements related to GCP activities. This position will support the design, implementation and maintenance of QA and compliance programs including, but not limited to, an SOP system, CAPAs, site and vendor audits and work closely with the Clinical Operations team.
Responsibilities:
Manage the GCP Quality interface and support for all Project Teams.
Manage GCP group functions to include clinical and non-clinical vendor audits, support clinical sites on compliance issues for Phase I-III trials, surveillance of Pharmacovigilance and product complaints activities, internal and external audits of data sources to ensure integrity and accuracy of study data, including, clinical research data and nonclinical data to support regulatory filings, and provided quality training of GLP/GCP staff.
Manage the conduct of GLP/GCP Internal and external global audits, facilitate product complaint reporting for investigation activities to ensure compliance with the FDA and EU and other regulations for clinical trials and nonclinical studies; implement corrective actions to resolve audit findings.
Provide QA review and approval for GCP regulatory submission documents.
Review & provide input on master service agreements and/or technical service agreements related to GLP/GCP.
Develop the CQA plans for Phase I-III trials and implemented the actions necessary for global clinical sites to comply with SOPs, study protocol, and country, federal, state, and local regulatory requirements.
Provide leadership to prepare global clinical sites, and GCP and GLP vendors for US FDA, GCP, EU inspections, and inspections by other regulatory government agencies.
Requirements:
Bachelor's Degree minimum: with focus in Chemistry, Life Sciences, Engineering or similar technical field.
GCP Experience Required specific QMS experience).
Management Experience Required
Management Experience Required
Relocation Assistance Available
10 to 15 years experience minimum in pharmaceutical industry Quality Assurance required.
Employment Type
Full Time
Company Industry
Key Skills
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