Director, QMS Process Owner - Global Change Control Management

Beigene; 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 is seeking a Director, QMS Process Owner - Global Change Control Management to lead the strategy, governance, harmonization, and performance of the company’s GxP Change Management across the product lifecycle. The role partners with Quality, Manufacturing, Regulatory Affairs, and external partners to drive risk-based changes and timely updates.

The successful candidate will have 10+ years in Quality Systems or related GxP functions, plus experience leading Change Control in a global

Qualifications

• 10+ years in Quality Systems or related GxP functions.
• Experience leading Change Control/Variation Management in a global environment.

Responsibilities

• Own the global GxP Change Management strategy and operating model across lifecycle.
• Lead risk-based simplification and digital transformation of Change Control processes.
• Coordinate complex global changes with multiple functions and partners.
• Develop harmonized Change Management pathways for new product introduction and lifecycle changes.
• Own governance forums and enterprise procedures to ensure right-first-time execution.

Skills

Quality Systems

Change Management

GxP

Regulatory Affairs

Project Management

Lean Six Sigma

Education

Bachelor’s degree in life sciences/engineering

Job description

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 management, or organizational change-management training or certification is a plus.

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $168,000.00 - $228,000.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.

The Company has a comprehensive benefits package that includes

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].