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Associate Director, Quality Assurance and Compliance
hace 2 meses
We are seeking a highly experienced and skilled Associate Director, Quality Assurance and Compliance to join our team at Biorasi. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and compliance in our clinical research operations.
Key Responsibilities- Lead Quality Systems and Assurance: Develop, implement, and maintain GCP Quality Systems and SOPs to ensure compliance with regulatory requirements.
- Train and Mentor Staff: Provide training and mentorship to staff on global GCP regulations and guidance to ensure a high level of understanding and adherence.
- QA Oversight and Auditing: Provide QA oversight and auditing of eTMFs to ensure accuracy and compliance.
- Lead Audits and Corrective Actions: Lead and/or oversee consultant-mediated audits, develop, recommend, and follow up on corrective actions to ensure timely resolution.
- Inspection Readiness: Lead preparations for Clinical Operations (corporate and third-party) inspection-readiness to ensure a smooth and successful inspection process.
- Lead GCP Inspections: Lead and manage GCP Inspections on behalf of Biorasi and Biorasi clients to ensure compliance and quality.
- Serve as SME: Serve as a Subject Matter Expert for areas of responsibility during regulatory inspections and directly manage inspection Ready-Room activities.
- Design and Implement Quality Management System: In partnership with the Clinical Operations, Regulatory, and Pharmacovigilance teams, design and implement a risk-based clinical Quality Assurance management system.
- Identify and Implement Solutions: Identify QA and compliance-related issues and implement solutions to ensure timelines are maintained.
- Establish Metrics and Reporting: Establish metrics and report the state of GCP Quality and compliance of clinical trials to senior management.
- Ensure Compliance: Ensure Clinical Operations activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standards.
- Provide Consultation: Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirements, and phase of study.
- Stay Up-to-Date: Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.
- Ensure Quality Systems and Procedures: Ensure that Biorasi quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines.
- Oversee Quality Assurance Audits: Oversee the planning and conduct of internal, investigator, and vendor Quality Assurance audits.
- Manage Quality Assurance Files: Manage the administration of Quality Assurance files and the control of central files.
- Education: Degree in biomedical sciences or related scientific discipline.
- Experience: 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.
- Skills: Strong planning, leadership, negotiation, communication, and presentation skills.
- Auditing Experience: Experienced with auditing clinical vendors and investigator sites.
- Regulatory Knowledge: Practical knowledge of GCP or GMP, and FDA regulatory structure.
- Technical Skills: Proficient with Microsoft Office tools.
