Associate Director, Global GCP QA

• Independently provide QA oversight for assigned clinical programs
• Ensure clinical phase and China clinical programs comply with applicable health authority regulations and guidelines
• Review key clinical and regulatory submission documents, including IND/NDA documents
• Identify and document vendor risks related to study compliance, data integrity, and participant safety
• Review clinical trial documentation for data integrity and GCP compliance
• Manage quality events and CAPAs, escalating significant risks appropriately
• Prepare quality metrics and trend analyses for management review
• Create, maintain, and improve quality SOPs, manuals, templates, process maps, and approval flows
• Provide quality guidance to clinical functions and implement fit-for-purpose GCP procedures
• Support continuous improvement initiatives and quality improvement projects
• Promote a culture of quality through communication, training, and stakeholder engagement
• Report key quality metrics to leadership
• Lead audits of studies, internal processes, investigator sites, vendors/CROs, TMFs, and CSRs
• Review audit findings and ensure effective root cause analysis and CAPAs
• Support GCP vendor qualification and oversight
• Evaluate and mitigate GCP compliance risks
• Support inspection readiness and lead assigned inspection workstreams
• Support global regulatory authority inspections
• Maintain current knowledge of agency and industry GCP trends, standards, and methodologies
• Report to the Executive Director, Global GCP, QA

Requirements

• BS/MS or equivalent in a scientific discipline required
• 8+ years of pharmaceutical/biotechnology experience
• At least 4 years in a GCP QA lead auditor role
• Prior experience supporting regulatory inspections (FDA, EMA, MHRA, NMPA, PMDA)
• Expertise in ICH E6, E8, E2A-F, 21 CFR Part 11, EU Annex 11, and other global standards
• Prior success executing QMS systems, including vendor management and system implementation
• Working knowledge of EDMS and other document and data management platforms
• Highly organized and detail-oriented, with the ability to manage multiple priorities
• Exceptional project management and communication skills
• Ability to drive outcomes across matrixed teams and third parties
• Strong strategic thinking and adaptability in a fast-paced, global environment
• Willingness to travel up to approximately 50% depending on location

Core Competencies

Demonstrates expertise in GCP compliance, quality assurance oversight, and regulatory submission processes within the pharmaceutical and biotechnology sectors. Proven ability to manage quality events, lead audits, and support inspection readiness while promoting a culture of quality across clinical functions.

Highest-signal resume keywords

• GCP Compliance
• Quality Assurance Oversight
• Regulatory Inspection Support
• Audit Management
• QMS System Implementation

ATS Optimization Keywords

Hard Skills

• GCP Standards
• IND/NDA Document Review
• CAPA Management
• Quality Metrics Analysis
• Risk Identification
• Vendor Management
• Document Management
• Root Cause Analysis
• Quality SOP Development
• Clinical Trial Documentation Review

Soft Skills

• Project Management
• Communication Skills
• Strategic Thinking
• Detail-Oriented
• Organizational Skills

Industry Keywords

• Pharmaceutical
• Biotechnology
• FDA
• EMA
• MHRA
• NMPA
• PMDA
• ICH E6
• 21 CFR Part 11
• EU Annex 11

Tools & Technologies

• EDMS
• Data Management Platforms
• Quality Management Systems