Director of GCP/QA - Advanced Recruiting Partners : Job Details

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