Director, QMS Process Owner - Global Change Control Management

BeOne Medicines USA; United States; Vor Ort; USD 180.000 - 260.000; Vollzeit

Zusammenfassung

BeOne Medicines USA seeks a Director, QMS Process Owner - Global Change Control Management to lead strategy, governance, and harmonization of change management across the product lifecycle. You will partner with Quality, Manufacturing, Regulatory Affairs, and IT to drive risk-based changes and measurable improvements.

The role demands strong technical judgment, enterprise leadership, and the ability to align diverse stakeholders while advancing digital transformation and right-first-time

Qualifikationen

• Bachelor's degree required; advanced degree preferred.
• 10+ years of relevant experience in Quality Systems, Quality Operations, Technical Operations, Manufacturing, Regulatory Affairs, or a related GxP function in pharma/biotech.
• Experience owning or leading Change Control, Variation Management, or other core QMS processes globally.
• Experience supporting new product introduction, technology transfer, manufacturing/analytical changes, commercialization, or lifecycle management.
• Experience with QMS transformation, workflow design, system implementation, validation, migration, reporting, automation, or digital adoption.
• Lean, Six Sigma, project management, quality risk.

Aufgaben

• 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 Change Control process with differentiated pathways and targets.
• Extend oversight to implementation readiness, execution quality, and evaluation of outcomes.
• Develop harmonized Change Management pathways across product lifecycle for new product introduction, technology transfer, manufacturing transfers, launch readiness, and commercialization.
• Coordinate with Regulatory Affairs to integrate regulatory commitments and timing into change planning and governance.
• Coordinate complex global changes across Manufacturing, QC, Supply Chain, Quality, Regulatory, sites, contract manufacturers, and external partners; clarify dependencies and risk.
• Establish strategic portfolio visibility for major changes to identify interdependencies and execution risks.
• Own Change Management analytics, including cycle-time analysis, trends, adoption signals, and improvement priorities.
• Lead governance forums (Global Change Control Review Board) and ensure clear decisions and actions.
• Maintain enterprise procedures, templates, training, and qualification approaches for consistent execution.
• Serve as the enterprise subject matter expert for Change Management questions, governance decisions, and escalations.
• Build trusted relationships and facilitate decisions when priorities conflict.
• Translate strategy into executable plans with visibility to commitments and risks.
• Perform other responsibilities as assigned.

Kenntnisse

Lean

Six Sigma

Project management

Quality risk

Ausbildung

Bachelor's degree in life sciences / engineering / quality management

Advanced degree preferred

Jobbeschreibung

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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