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Associate Director, Quality Assurance and Compliance
hace 2 meses
Biorasi is seeking a highly experienced Associate Director, Quality Assurance and Compliance to lead the development, implementation, and maintenance of GCP Quality Systems and SOPs. This is a critical role that requires a strong understanding of global GCP regulations and guidance.
Key Responsibilities- Lead the development, implementation, and maintenance of GCP Quality Systems and SOPs
- Train and mentor staff on global GCP regulations and guidance
- Provide QA oversight and auditing of eTMFs
- Lead and/or oversee consultant-mediated audits; develop, recommend, and follow up on corrective actions
- Lead preparations for Clinical Operations (corporate and third-party) inspection-readiness
- Lead and manage GCP Inspections on behalf of Biorasi and Biorasi clients
- Serve as an SME for areas of responsibility during regulatory inspections, and directly manage inspection Ready-Room activities
- In partnership with the Clinical Operations, Regulatory, and Pharmacovigilance teams, design and implement a risk-based clinical Quality Assurance management system
- Identify QA and compliance-related issues and implement solutions to ensure timelines are maintained
- Establish metrics and report the state of GCP Quality and compliance of clinical trials to senior management
- Ensure Clinical Operations activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standards
- Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirements, and phase of study
- Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.
- Ensure that Biorasi quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines
- Ensure that Biorasi standard operating procedures (SOPs) are compliant with applicable regulations and guidelines
- Oversee the planning and conduct of internal, investigator, and vendor Quality Assurance audits
- Manage the administration of Quality Assurance files and the control of central files
- Degree in biomedical sciences, related scientific discipline
- 10+ years in drug development or clinical research within the pharmaceutical industry or CRO with at least three years in quality assurance, quality management, or clinical safety-related area of responsibility
- Strong planning, leadership, negotiation, communication, and presentation skills
- Experienced with auditing clinical vendors and investigator sites
- Practical knowledge of GCP or GMP, and FDA regulatory structure
- Proficient with Microsoft Office tools
