The GCP Audit Management Associate Director is responsible for the oversight and management of quality activities related to GCP activities (internal and external), including the oversight of GCP Vendors and Clinical Investigator site compliance, developing and executing audit plans and onsite vendor and CI audits, supporting inspection management and support activities, etc. This role will be responsible for working independently, collaborating with other Audit and Inspection team members and responsible for the successful execution of the GCP Audit and Inspection Preparation and Management Program.
Key Duties and Responsibilities:
Serves as Lead of the GCP Audit function with responsibility for the overall planning, execution and effectiveness of the audit program in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with GCP regulatory requirements, and guidance
Partners with QA leadership and business leadership for coordination and alignment in confirming overall quality of audit and adequacy in remediation/improvement across vendors and internal operations
Maintains the integrated and risk-based GCP Audit Plan and provides direction to plan execution and adherence. Partners with and engages stakeholders and leadership across functional areas and QA in risk evaluation when determining the internal audit schedule.
Develops, maintains, and executes strategic Audit Plans for to support audits (GCP)
Conducts/oversees GCP Vendor qualification and requalification audits
Conducts/oversees CI audits
Provides oversight, including budget forecast and tracking, for audits that are outsourced
Executes directed or For-Cause audits, as needed
Engages in Preparation, Support and Follow-up activities for Regulatory Inspections.
Supports due-diligence and business development activities, as requested
May serve as GCP Quality Management System representative
Participates in collaborative review of impacted SOP/WI
Reviews and analyzes key Performance Indicator data and trends
Analyzes risk and proposes remedial, corrective and /or preventive actions
May participate on process improvement initiatives
Required Education Level
Bachelor's degree in relevant field is required or demonstrable equivalent experience.
Typically requires 8 years' experience or the equivalent combination of education and experience
Required Knowledge and Skills
GCP Audit processes
GCP Quality Systems
Global GCP regulations (US/EU etc.); ICHE6 R2, 21 CFR Part 50, 54, 56, 312, 314, and high level knowledge of 21 CFR Part 11 and International equivalents as necessary
GCP Documentation (e.g., CSRs, IBs, NDA Submissions etc.)
Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
Risk management principles and process, change management