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Director of GCP/QA
3 months ago
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
- 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
- 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
