VP Global Process Management
Jobtailor
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. Requirements 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. #J-18808-Ljbffr Jobtailor
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