Director, Global GCP QA

Stellenbeschreibung:

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.