Global QMS Change Leader - Director, Process Owner

BeOne Medicines USA; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Lean

Six Sigma

Project management

Quality risk

Education

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

Advanced degree preferred

Job description

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