Director, QMS Process Owner – Global Change Control Management

BeOne Medicines

. Own the global GxP Change Management strategy and operating model, including governance, process architecture, decision rights, roles, escalation pathways, and enterprise standards .

Posted 10/27/2026full-timeRemote • United StatesLead💰 $168,000 - $228,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Global Change Management, including governance, process architecture, and risk-based simplification. Proven ability to lead cross-functional teams and manage complex global changes while ensuring compliance with regulatory commitments.

Highest-signal resume keywords

Change Control LeadershipQuality Management Systems (QMS)Regulatory Affairs ExperienceProcess Oversight and ExecutionLean and Six Sigma Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Change Management StrategyProcess ArchitectureRisk-Based SimplificationImplementation ReadinessPerformance Indicators AnalysisWorkflow DesignSystem ImplementationValidationAutomationDigital Adoption

Soft Skills

Collaborative Relationship BuildingCoaching and MentoringDecision FacilitationStakeholder EngagementCommunication

Certifications & Qualifications

Lean CertificationSix Sigma CertificationProject Management Certification

Industry Keywords

GxPQuality OperationsTechnical OperationsManufacturingBiotechnologyPharmaceuticalChange ManagementVariation ManagementProduct Lifecycle ManagementQuality Risk Management

About the role

Key responsibilities & impact

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
Extend process oversight to implementation readiness, execution quality, effectiveness evaluation, and intended outcomes
Develop harmonized Change Management pathways throughout the product lifecycle
Integrate regulatory commitments, variations, market-specific requirements, and implementation timing into change planning and governance
Coordinate complex global changes across internal functions, sites, contract manufacturing organizations, and external partners
Establish strategic portfolio visibility for major changes and identify interdependencies, resource conflicts, and execution risks
Own Change Management intelligence and analytics, including performance indicators, cycle-time and bottleneck analysis, trends, adoption signals, and improvement priorities
Lead governance forums, including the Global Change Control Review Board and process stakeholder network
Maintain and improve enterprise procedures, work instructions, templates, decision tools, training, and qualification approaches
Serve as the enterprise subject matter expert and primary accountability point for Global Change Management questions, governance decisions, significant issues, audits, inspections, management reviews, and escalations
Build collaborative relationships and facilitate timely decisions across functions, sites, and regions
Provide coaching and expectations to change owners, reviewers, and stakeholders
Translate strategy into executable plans and deliver high-quality outcomes
Perform other responsibilities as assigned

Requirements

What you’ll need

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

Benefits

Comp & perks

Annual bonus plan for non-commercial roles
Incentive compensation plan for commercial roles
Discretionary equity awards
Employee Stock Purchase Plan
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness