What are the responsibilities and job description for the Senior Director Quality GCP position at Clinical Dynamix?
How you’ll contribute :
- Lead development and execution of the Clinical Quality strategy while ensuring that it aligns with Company’s business strategy, GCP / GLP / GVP standards, and FDA / EMA / ICH requirements
- Develop, implement and monitor phase appropriate GCP / GLP / GVP Quality programs, policies and procedures to ensure compliance with applicable regulations
- Develop, implement and execute a risk-based audit strategy for clinical and non-clinical studies
- Lead and manage GLP / GCP / GVP audits program including oversight of consultant mediated and / or self-conducted Vendor, System, Study, and Process audit
- Providing quality oversight and compliance support to all GLP non-clinical and clinical development programs including the development of strategic clinical quality oversight plans
- Serve as a member of clinical study teams, providing compliance guidance, to achieve continuous quality improvement and effective quality assurance
- Implement tolerance limits, metrics and key performance indicators to drive quality compliance and continuous improvement
- Provide day-to-day quality and compliance support, including issue management (triage / investigation / actions)
- Assist and advise in the development of CAPA plans in response to Quality events / audits / inspections and follow-up on CAPAs
- Participate in the evaluation and selection of CROs and other GLP / GCP / GVP service providers and establish Quality Agreements, as required
- Provide training sessions and mentor teams on topics related to GLP / GCP / GVP quality and related global regulations
- Review key non-clinical, safety and clinical documents including protocols / amendments, reports, study plans and regulatory documents
- Maintain an inspection awareness culture leading to a successful Inspection Readiness Program
- Establish Quality management governance and escalation structure and periodically report the state of R&D Quality and compliance to management at the Quality Management Review
Skills and experience you’ll bring :
