Director, QMS Process Owner – Global Change Control Management
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Job Description
Leading BeOne’s global pharmaceutical GxP Change Management strategy and QMS transformation. Governing change control, analytics, lifecycle execution, and cross-functional quality improvements.
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
- 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:
- 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:
- 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
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