Global QMS Change Leader: Strategy & Transformation

BeiGene, Ltd.; United States; Remote; USD 168,000 - 228,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. seeks a Director, QMS Process Owner - Global Change Control Management to lead the strategy, governance, and harmonization of our GxP Change Management across the product lifecycle.

You will partner with Regulatory, Manufacturing, QC, and others to ensure risk-based, timely changes and measurable improvements. The role requires 10+ years in Quality Systems or related GxP functions within pharma/biotech, with senior leadership experience and a track record in change

Qualifications

• 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.

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 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.

Skills

Change Control

Variation Management

QMS process

Quality Systems

Global leadership

Lean Six Sigma

Education

Bachelor's degree in life sciences, engineering, quality management, or a related field

Job description

BeOne Medicines Ltd. seeks a Director, QMS Process Owner - Global Change Control Management to lead the strategy, governance, and harmonization of our GxP Change Management across the product lifecycle.

You will partner with Regulatory, Manufacturing, QC, and others to ensure risk-based, timely changes and measurable improvements. The role requires 10+ years in Quality Systems or related GxP functions within pharma/biotech, with senior leadership experience and a track record in change