VP Global Process Management

Responsibilities

• Lead global process ownership and governance for enterprise Quality processes, including CAPA, deviations/non-conformance, change control, quality risk management, training, quality systems, and related processes.
• Define and maintain global process standards, procedures, roles and responsibilities, governance forums, and performance expectations to support compliant and consistent execution.
• Partner with cross-functional leaders to align Quality process strategy with business priorities, regulatory expectations, and operational needs across the global network.
• Lead simplification, harmonization, and continuous improvement initiatives that reduce variability, improve cycle times, strengthen compliance, and enhance user experience.
• Provide strategic leadership for digital Quality systems and eQMS optimization, including workflow design, data standards, system requirements, user roles, and inspection‑ready documentation.
• Establish and monitor global Quality performance metrics, dashboards, and management review mechanisms to identify trends, risks, and improvement opportunities.
• Support regulatory inspections, audits, and remediation activities by ensuring process design, governance, and execution meet applicable global requirements.
• Lead global councils, communities of practice, and change‑management efforts to drive adoption, capability building, and sustained process performance across a matrixed organization.

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related scientific discipline is required; advanced degree such as an M.S., MBA, Ph.D., Pharm.
  
  D., or equivalent is preferred.
• Minimum of 15 years of experience in pharmaceuticals, biotechnology, medical devices, or another highly regulated industry.
• Significant leadership experience in Quality, Quality Systems, Quality Operations, Compliance, or related functions within a global regulated environment.
• Demonstrated experience leading global teams, enterprise processes, or matrixed transformation initiatives; people management experience is required.
• Deep knowledge of GxP requirements and global regulatory expectations, including FDA, EMA, PMDA, MHRA, and ICH guidelines.
• Strong expertise in Quality Management Systems, including CAPA, deviations/non‑conformance, change control, investigations, document management, training, and quality risk management.
• Experience with digital Quality systems, eQMS platforms, data integrity principles, global data standards, and inspection readiness.
• Demonstrated ability to influence senior stakeholders, lead through ambiguity, drive enterprise alignment, and communicate effectively with executive leaders and regulatory audiences.