Manager, Clinical Quality Assurance

Job Description
Draft, review, revise or provide input to GCP/GLP/GVP SOPs to assess consistency and compliance with regulatory requirements/internal standards
Attend cross-functional team meetings and provide guidance to GCP/GLP/GVP functional groups based on interpretation of current regulations to ensure best practices including risk-based management
Work closely with GCP/GLP/GVP functional groups to ensure/coordinate appropriate and complete resolution of findings/non-compliances, deviations, investigations, CAPAs in a timely manner, including oversight and approval of all abovementioned activities, as necessary.
Assist and participate in various audits (e.G. clinical site audits, vendors, internal systems), as needed
Work directly with third party vendors and contractors, managing effective chain of communication related to GCP/GLP/GVP compliance
Interact with contract auditors facilitating scheduling audits, conducting pre-audit meetings, drafting audit plans, agendas, audit reports, and confirmation letters as appropriate
Oversee the audit response process and ensure acceptability of actions addressing findings fetched during the various audits.
Provide QA review of various procedures, clinical protocols, investigators brochure, clinical study reports and pharmacovigilance system management files and other relevant documents as needed
Escalate issues of critical and major non-compliances and/or lack of urgency in remediation as appropriate
Participate and/or conduct independent root cause analysis of various deviations and/or quality issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements
Assist with inspection readiness, and participate in regulatory inspections as needed