Director, QMS Process Owner - Global Change Control Management

Essential Functions of the Job

• Own the global GxP Change Management strategy and operating model, including governance, process architecture, decision rights, roles, escalation pathways, and enterprise standards.
• Lead risk-based simplification and digital transformation of the existing Change Control process by defining differentiated pathways, approval expectations, and performance targets proportionate to change complexity and risk.
• Extend process oversight beyond record approval and closure to implementation readiness, execution quality, effectiveness evaluation, and realization of intended outcomes.
• Develop harmonized Change Management pathways throughout the product lifecycle for new product introduction, technology transfer, manufacturing transfers and changes, launch readiness, and commercialization.
• Partner with Regulatory Affairs to integrate regulatory commitments, variations, market-specific requirements, and implementation timing into change planning and governance.
• Coordinate complex global changes across Manufacturing, QC, Supply Chain, Quality, Regulatory, sites, contract manufacturing organizations, and other external partners; clarify dependencies, accountability, risk, and escalation needs.
• Establish strategic portfolio visibility for major changes across products, sites, and external partners to identify interdependencies, resource conflicts, and execution risks requiring leadership attention.
• Own Change Management intelligence and analytics, including process-performance indicators, cycle-time and bottleneck analysis, recurring trends, adoption signals, and improvement priorities.
• Lead governance forums, including the Global Change Control Review Board and process stakeholder network, ensuring decisions and actions are clear, documented, assigned, and completed.
• Maintain and improve enterprise procedures, work instructions, templates, decision tools, training, and qualification approaches that support consistent and right-first-time execution.
• Serve as the enterprise subject matter expert and primary point of accountability for Global Change Management questions, governance decisions, significant issues, audits, inspections, management reviews, and escalations.
• Build trusted, collaborative relationships and facilitate timely decisions when functions, sites, or regions have competing priorities or different risk perspectives.
• Provide practical coaching and clear expectations to change owners, reviewers, and stakeholders; address execution gaps directly and constructively.
• Translate strategy into executable plans, maintain visibility to commitments and risks, and consistently deliver high-quality outcomes in a fast-moving environment.

Qualifications

• Bachelor's degree in life sciences, engineering, quality management, or a related field required. Advanced degree preferred.
• 10+ years of relevant experience in Quality Systems, Quality Operations, Technical Operations, Manufacturing, Regulatory Affairs, or a related GxP function within the pharmaceutical or biotechnology industry.
• Demonstrated ownership or senior leadership of Change Control, Variation Management, or another core QMS process in a global environment.
• Experience supporting new product introduction, technology transfer, manufacturing or analytical changes, commercialization, or product lifecycle management strongly preferred.
• Experience with QMS transformation, workflow design, system implementation, validation, migration, reporting, automation, or digital adoption preferred.
• Lean, Six Sigma, project management, quality risk management, or organizational change-management training or certification is a plus.