Sr Director, Clinical Quality Assurance (GCP)
The Sr. Director, Clinical Quality Assurance has overall responsibility for effectively providing quality oversight and support to all clinical development programs. They will have the overall responsibility for building a Clinical Quality Assurance function and ensure GCP, GLP and GVP compliance.
- Develop, implement and maintain GCP/GLP quality oversight systems through development of procedures that follow 21 CFR Part 50, 56, 58 and 312 along with ICH E6 and other relevant guidance documents.
- Provide expertise and guidance in interpreting global government regulations and guidelines relevant to clinical trials (GCP) and pharmacovigilance (GVP).
- Develop and implement full contract research organization (CRO) and clinical site qualification program through risk-based auditing program, including developing annual GCP and GLP auditing plan for all ongoing and completed clinical studies and laboratories. Provide active monitoring of vendors and clinical investigators to assure GCP compliance.
- Manage and oversee vendor or site inspection readiness for regulatory inspections (FDA, EMA, etc.), including periodic review of the TMF. Assume a lead role for the preparation, conduct, and responses to regulatory agency.
- Collaborate and work closely with the Clinical Operations team, CROs and clinical sites to effectively and efficiently set up the overall GCP oversight programs to ensure compliance with US and other regulatory jurisdiction requirements.
- Maintain study drug un-blinding information to facilitate emergency un-blinding needs.
- Evaluate quality events, incidents, queries, and complaints and perform risk analysis on any GCP violation reported from the clinical site or CROs (including CTM service provider), take actions to remediate, and communicate to senior management on the overall compliance status.
- Perform QC checks of relevant clinical documents and regulatory dossiers, e.g., Investigator’s Brochure, CRF, Clinical Study Reports and non-clinical/clinical sections in the IND/NDA/BLA/MAA submission to ensure data integrity and accuracy.
- Work with Clinical Operations and PVG department to develop a robust and integrated risk management program in accordance with ICH E6 (R2), including systems and processes associated with product complaints.
- Develop and author clinical QA related SOPs for continuous improvements of QMS.
- Represent clinical QA and provide quality updates as required at all levels of the organization.
- Provide leadership and strategy in spear heading Quality initiatives line with company objectives.
- Other QA related duties as assigned
- Bachelor degree or advanced degree in a scientific or related discipline.
- At least 12-15 years of experience in an industry clinical setting in a GCP quality role or as a Clinical Research Manager, with at least 7 - 10 years leading the GCP and quality function.
- Demonstrated strong leadership skills with excellent interpersonal, verbal and written communication skills. A people manager with good listening skills, interpersonal savvy, and ability to work with key stakeholders and across various functions at all levels of the organization.
- Proven experience leading GCP audits and conducting quality assessment of TMFs.
- Strong understanding of GCP/GLP and pharmacovigilance global regulations and guidances.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Expert understanding in the effective management of modern quality systems.
- Willing to travel at least 25% of the time.