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Director of Quality Assurance and Compliance
hace 2 meses
Biorasi is seeking a highly experienced and skilled Associate Director of Quality Assurance to lead our quality assurance and compliance efforts. As a key member of our team, you will be responsible for ensuring that our clinical trials are conducted in accordance with Good Clinical Practice (GCP) regulations and guidelines.
Key Responsibilities- Lead the development, implementation, and maintenance of GCP quality systems and standard operating procedures (SOPs)
- Train and mentor staff on global GCP regulations and guidance
- Provide QA oversight and auditing of electronic Trial Master Files (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 a subject matter expert (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.
- 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
- Half-day Fridays
- Paid time off
- Paid holidays
- Extensive country-specific benefits
- Employee bonus programs
- Career growth
- Training and development
Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
