Director, QMS Process Owner – Global Change Control Management

🕒 Outubro 27

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $168.000 - $228.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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• Aberta há 16 dias.
• As vagas desta empresa costumam ser preenchidas em 41 dias.

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BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

Biotechnology • Healthcare • Pharmaceuticals

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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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