Director, QMS Process Owner – Global Change Control Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of the global GxP Change Management strategy and operational framework, encompassing governance, process architecture, decision rights, roles, escalation pathways, and enterprise standards.

• Spearhead risk-based simplification and the digital transformation of the current Change Control process.

• Expand process oversight to include implementation readiness, execution quality, effectiveness assessment, and anticipated outcomes.

• Create unified Change Management pathways throughout the product lifecycle.

• Incorporate regulatory obligations, variations, market-specific requirements, and implementation timelines into change planning and governance.

• Coordinate intricate global changes across internal functions, sites, contract manufacturing organizations, and external partners.

• Establish strategic portfolio visibility for significant changes while identifying interdependencies, resource conflicts, and execution risks.

• Manage Change Management intelligence and analytics, which include performance indicators, cycle-time and bottleneck analysis, trends, adoption signals, and areas for improvement.

• Lead governance forums such as the Global Change Control Review Board and the process stakeholder network.

• Sustain and enhance enterprise procedures, work instructions, templates, decision tools, training, and qualification approaches.

• Act as the enterprise subject matter expert and primary accountability contact for Global Change Management inquiries, governance decisions, significant issues, audits, inspections, management reviews, and escalations.

• Foster collaborative relationships and enable timely decision-making across functions, sites, and regions.

• Provide guidance and set expectations for change owners, reviewers, and stakeholders.

• Convert strategy into actionable plans and ensure high-quality outcomes.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

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

• Over 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.

• Proven ownership or senior leadership in Change Control, Variation Management, or another core QMS process in a global context.

• Strong preference for experience in supporting new product introductions, technology transfers, manufacturing or analytical changes, commercialization, or product lifecycle management.

• Preferred experience in QMS transformation, workflow design, system implementation, validation, migration, reporting, automation, or digital adoption.

• Training or certification in Lean, Six Sigma, project management, quality risk management, or organizational change management 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.