Head of Global GxP Quality

Role Summary

Head of Global GxP Quality to lead our Quality organization across both commercial and clinical operations. Responsible for building and leading a global, integrated GxP Quality function, spanning GMP, GDP, GCP, GLP, Quality Systems, Quality Control, EU Quality, and post-market surveillance, ensuring regulatory compliance, global inspection readiness, and operational excellence across the product lifecycle.

Responsibilities

• Strategic Leadership: Develop and execute global GxP Quality strategy across clinical and commercial programs, ensuring alignment with global regulatory expectations (FDA, EMA, ICH).
• Regulatory Representation: Serve as the executive Quality representative for regulatory inspections (e.g., FDA PAI, EMA MAA) and major health authority interactions.
• Cross-Functional Collaboration: Collaborate with Manufacturing, Supply Chain, Regulatory, and Clinical leaders to embed Quality into end-to-end business processes.
• Quality Functional Oversight:
  • GMP Quality Assurance: Oversee DS, DP, and finished goods quality across internal operations and external CDMOs; ensure compliant batch disposition and vendor oversight.
  • R&D Quality (GCP/GLP): Lead quality oversight across clinical and nonclinical development programs, including GCP compliance, CRO/vendor qualification, clinical site audits, TMF management, inspection readiness, and GLP oversight for IND-enabling studies.
  • EU Quality & QP Oversight: Ensure compliance with EU GDP/importation requirements and oversight of QP batch certification and market release processes.
  • Quality Control (QC): Oversee release and stability testing, method validation/transfer, reference standards, and specification lifecycle management.
  • Quality Management Systems (QMS): Own and evolve the global QMS, including deviation/CAPA management, change control, documentation, training, and internal/external audit programs.
  • Post-Market Surveillance: Establish and oversee global processes for product quality complaints, field alert reporting, investigation closure, and post-market reporting compliance.
• Team Leadership & Governance: Build and lead a high-performing global Quality organization, define and monitor Quality performance metrics, drive continuous improvement, and ensure systems readiness for global scale; represent Quality in executive governance forums and launch readiness reviews.

Qualifications

• 15+ years of progressive leadership in biopharmaceutical Quality, including experience supporting global commercial launches and late-stage clinical development.
• Deep expertise across GMP, GCP, GLP, GDP, and Quality Systems, with track record of leading organizations through regulatory inspections (FDA, EMA, etc.).
• Experience managing external partners (CDMOs, CROs, testing labs) in a virtual or hybrid operating model.
• Strong understanding of regulatory expectations for global post-market quality systems, including complaint management and field alert reporting.
• Proven ability to scale Quality organizations and systems to support commercial expansion and global operations.
• Excellent communication, leadership presence, and cross-functional collaboration skills.
• Bachelor’s degree in life sciences or related field required; advanced degree preferred.

Skills

• Strategic Quality Leadership
• Regulatory Inspection Readiness
• GxP Compliance (GMP, GDP, GCP, GLP)
• Quality Systems Management
• Partner/Vendor Management
• Cross-Functional Collaboration

Education

• Bachelor’s degree in life sciences or related field; advanced degree preferred.

Additional Requirements

• Location and travel details not specified in source.