Director, Global GCP QA

• Act as the primary GCP QA subject matter expert and point of contact for assigned early- and late-phase clinical and China clinical programs
• Ensure clinical programs comply with applicable health authority regulations and guidelines
• Provide quality oversight and review key clinical and regulatory submission documents, including IND/NDA documents
• Own and implement the risk-based GCP audit and compliance strategy across the clinical portfolio
• Establish GCP quality governance forums and provide compliance reports to senior leadership
• Lead assessment and escalation of significant quality events, serious breaches, systemic trends, and critical and major CAPAs
• Monitor adverse trends, manage issue trends, and make recommendations to management
• Provide strategic oversight of CROs and other critical clinical vendors
• Manage or mentor GCP QA employees, consultants, and contracted auditors
• Represent GCP QA in governance committees and major program decisions
• Assess and manage vendor-related risks affecting study compliance, data integrity, and participant safety
• Review clinical trial documentation for data integrity and GCP compliance
• Create, maintain, and improve quality SOPs, manuals, templates, process maps, approval flows, and the GCP QMS
• Drive continuous improvement across Global QA processes
• Partner with clinical functions to implement fit-for-purpose GCP procedures
• Promote a culture of quality through communication, training, and stakeholder engagement
• Report key quality metrics to leadership
• Develop strategies and execute or lead routine and for-cause audits of studies, internal processes, investigator sites, vendors/CROs, TMFs, and CSRs
• Approve audit findings, reports, root cause analyses, action plans, and audit CAPAs
• Lead and oversee GCP-related vendor qualification and oversight
• Evaluate and mitigate GCP compliance risks
• Lead sponsor inspection readiness and regulatory inspection activities, including inspection strategy, front-room/back-room execution, and response development
• Support global regulatory authority inspections and lead or support site and vendor inspection readiness
• Maintain current knowledge of agency and industry GCP trends, standards, and methodologies

Requirements

• BS/MS or equivalent in a scientific discipline required
• Advanced degree preferred
• Auditor certifications and/or SQA RQAP credentials preferred
• 10+ years of pharmaceutical/biotechnology experience
• At least 7+ years in a GCP QA lead auditor role
• Prior experience in Big Pharma preferred
• Proven leadership supporting regulatory inspections, including FDA, EMA, MHRA, NMPA, and PMDA
• Expertise in ICH E6, E8, E2A-F, 21 CFR Part 11, EU Annex 11, and other global standards
• Prior success designing and executing QMS systems, including vendor management and system implementation
• Working knowledge of EDMS and other document and data management platforms
• GCP QA experience required
• Ability to manage multiple priorities in a fast-paced, evolving environment
• Exceptional leadership, 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
• Travel required: up to approximately 50% depending on location

Core Competencies

Demonstrates expertise in GCP QA processes, regulatory compliance, and quality oversight in clinical programs. Proven ability to lead audits, manage vendor relationships, and drive continuous improvement in quality management systems.

Highest-signal resume keywords

• GCP QA Experience
• Regulatory Inspection Leadership
• ICH E6, E8, E2A-F Expertise
• Auditor Certifications
• Pharmaceutical/Biotechnology Experience

Hard Skills

• GCP Compliance
• Quality Oversight
• Risk-Based Audit Strategy
• Clinical Trial Documentation Review
• QMS System Implementation
• Data Integrity Management
• CAPA Management
• Vendor Qualification
• Regulatory Submission Review
• Adverse Trend Monitoring

Soft Skills

• Leadership
• Project Management
• Communication
• Strategic Thinking
• Adaptability

Certifications & Qualifications

• Auditor Certifications
• SQA RQAP Credentials

Industry Keywords

• FDA
• EMA
• MHRA
• NMPA
• PMDA
• Big Pharma
• Clinical Programs
• Health Authority Regulations
• Quality Governance
• Continuous Improvement

Tools & Technologies

• EDMS
• Document Management Platforms
• GCP QMS