Director, QMS Process Owner - Global Change Control Management

General Description:

The Director, QMS Process Owner - Global Change Control Management is accountable for the strategy, governance, harmonization, performance, and continuous improvement of BeOne’s global GxP Change Management process across the product lifecycle. The role evolves traditional Change Control ownership into a broader enterprise capability that enables effective, risk-based change, timely product introduction and updates throughout lifecycle management, reliable implementation, and sustained outcomes. The position partners across Quality, Manufacturing, QC, Supply Chain, Regulatory Affairs, Technical Operations, Digital/IT, sites, and external partners to simplify execution, integrate complex changes, and translate process data and risk signals into clear decisions and measurable improvement. The successful candidate combines deep technical judgment with strong enterprise leadership, practical problem solving, disciplined follow-through, and the ability to build alignment across diverse stakeholders.

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.

• Perform other responsibilities as assigned.

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.