Director, QMS Process Owner – Global Change Control Management

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $168k - $228k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 1%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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