Associate Director/Director, Clinical Quality Assurance
-~7-10 yrs total clinical research experience
-Some experience working for a CRO
-Strong collaborator. Very knowledgeable of FDA regulations and ICH/GCG
-Salary range: $130K-170'sK
Director, Quality Assurance-mid-sized, woman-owned, CRO client
Job Location: either in-house in Bay Area, CA or RTP, NC OR home office based/remote anywhere
Mid-sized, Bay area based CRO, immediate opening for a Director, Clinical Quality Assurance. In house position or remote, home-based. The Director, Quality Assurance (Director, QA), is responsible to develop, establish and oversee CRO Quality systems and processes to ensure quality client services, clinical research processes and comply with regulatory requirements. The Director, QA will perform the following essential duties either directly or through the appropriate use of resources including, direct reports, indirect reports, or consultants.
- · Manages company Controlled Documents system (Standard Operating Procedures SOP, Guidelines, and Policies).
- · Manage and/or conduct QA audits of internal clinical processes and vendors.
- · Manages corrective and preventative action program (CAPA), including communication to senior management and clients, as appropriate.
- · Manages corporate training files (tracking, filing) processes and training related to client and agency inspections.
- · Prepares staff for client audits and Health Authority inspections, management of the audit/inspection process, and provide/review corrective and preventative action responses associated with audits/inspections.
- · Coordinates and provides GCP training to ensure that staff is up to date on required regulatory requirements and trends.
- · Keeps abreast of regulatory updates and is a resource for improving processes, and communicates information to staff either through training programs or other Company communication channels.
- · Works closely with the senior management team regarding quality processes, issues, resolution, and documentation.
- · Develops and manages budget for Quality Assurance functional area.
- BS, BA, or other 4-year degree, preferably related to business or quality systems (nurse without degree will work).
- · 8+ years of quality assurance-related experience, preferably in the medical device or pharmaceutical industry.
- · Current education or training related to quality management and/or membership in a quality-focused organization.
- · 5+ years of demonstrated progressive people leadership.
- Good Clinical Practice experience (GCP) is required.
- · Knowledge and experience of the pharmaceutical, and /or medical device industry, preferably as Quality Auditor and/or Quality Manager.
- · Demonstrated experience in negotiation and persuasion skills.
- · Demonstrated ability to make sound judgments/decisions.
- · Excellent written and verbal communication skills, including presentation and analytical reporting.
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