What are the responsibilities and job description for the Director of GCP/QA position at Advanced Recruiting Partners?
Job Description
Determine risk-based intervals for audits of non-GMP vendors and ensure compliance with agreed-upon schedules
Conduct or assign the conduct of all scheduled non-GMP Vendor Qualification Audits, ensuring timely reporting and follow up
Serves as QA primary point of contact for designated clinical studies, attending routine update meetings and ensuring the actioning and completion of study-specific QA activities; provides QA review of project-specific planning documents, as needed, unless delegated
Ensures the implementation of a risk-based Clinical Quality Management Plan for all clinical studies intended for registration
Ensures the timely conduct, reporting, and follow up for non-GMP Internal QA Audits, as assigned, ensuring timely conduct, reporting, and follow up :
Schedule, conduct and provide timely reports of audits to assure conformance with the approved audit schedule, and to confirm compliance with regulations, guidelines, SOPs, and Industry standards
Effectively communicate actionable findings to various staff levels. Effectively present findings to ensure clear understanding of deficiencies (verbal and written)
Ensures clinical study protocols and reports are reviewed to assure quality, consistency, and compliance
Performs initial and / or technical review of draft GCP quality agreements prior to signatory review, as requested
Works to maximize the use of the electronic quality management system (eQMS) for quality workflows and for the effective tracking, trending, and reporting of quality data and information
Oversees the planning and performance of compliance audits of foreign and domestic clinical investigators to verify protection of human research participants, data integrity, and regulatory and protocol compliance
Writes, revises, and periodically reviews SOPs to further develop the Quality System and control over compliance and the quality of data, vendor services, and products
Ensures the timely and complete handling and documentation of quality incidents and investigations, root cause analyses, risk assessments and risk impact analyses, as well as corrective and preventive actions (CAPAs)
Clearly communicates quality, compliance, and audit issues to internal and external parties, professionally, and in a timely manner
Supports Regulatory Compliance and Inspection Activities :
Oversees the preparation of investigators and vendors for potential / impending audits and inspections
Conducts QA review of project-specific documents, as assigned
Supports the preparation, coordination, and management of regulatory agency inspections
Perform other quality assurance advisory duties as assigned by the Head of QA
Job characteristics :
Working independently in a geographically distributed team
Being proactive, target-driven, and diligent
Working with multiple stakeholders and managing multiple priorities
Contributing to an overall culture of quality within the organization
Participating in cross-functional conversations and decision-making around complex quality, compliance, and risk situations
Skilled in negotiation and communicating internally and externally with personnel of all levels of seniority
Requirements :
8 years working in GCP Quality Assurance and Quality Management
BA in scientific field, or BA in non-science field with additional 2 years relevant work experience
Advanced degree preferred
Documented training on and knowledge of current FDA Regulations and GCPs
Experience and expertise in conducting and reporting GCP vendor audits, clinical investigator audits, and protocol and report audits
Proficient written and verbal communication skills
Ability to collaborate effectively with cross functional team members and external partners
Ability to manage multiple QA activities across multiple programs and studies
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