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Director of Quality Assurance and Compliance
hace 2 meses
Job Title: Associate Director, Quality Assurance
Job Summary:
We are seeking a highly experienced and skilled Associate Director, Quality Assurance to join our team at Pharmiweb. The successful candidate will be responsible for leading the development, implementation, and maintenance of quality systems and SOPs, as well as providing QA oversight and auditing of eTMFs.
Key Responsibilities:
- Lead 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 Pharmiweb and Pharmiweb 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 Pharmiweb quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines.
- Ensure that Pharmiweb 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.
Requirements:
- 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.
