Director, Global Clinical Supply Compliance (Hybrid)

MSD • Rahway, NJ

1d • Hybrid

About The Position

The Director in Global Clinical Supply (GCS) Compliance is a technical leader responsible for governing and advancing GCS’s global GxP Quality Systems to ensure the organization executes clinical supply operations in a compliant, inspection‑ready, and risk-based manner. GCS supports Phase I–IV trials across 60+ countries in alignment with local and regional regulations for GxP (GMP, GDP, and GCP) and Environmental Health & Safety. This role provides global‑level oversight and strategic direction across key GCS compliance processes—including deviations, CAPA, change control, documentation, training, audits/inspections, analytics, risk management, and safety—while recognizing that individual depth may vary by area. Directors are expected to lead broadly across these domains and apply deeper expertise where their strengths align. The Director partners closely with GCS functional areas and stakeholders within Development Sciences and Clinical Supply, our Research & Development Division Quality Assurance, Global Development Quality, IT/Digital, GCTO, Procurement, and other enterprise stakeholders to drive compliance strategy, QMS alignment, and performance improvement within GCS.

Requirements

• Bachelor’s degree in a Scientific, Engineering, or related field with 10+ years of relevant experience in a regulated GxP environment; or master’s degree with 8+ years of experience in compliance, quality, technical operations, or related disciplines.
• Experience leading or governing multiple GxP Quality Systems (e.g., deviations, CAPA, change control, documentation, training, audits/inspections, risk management, safety) is required.
• Demonstrated experience influencing cross-functional teams across global or multi-site organizations.
• Ability to provide strategic oversight and governance for GxP processes across deviations, CAPA, change control, documentation, training, risk management, and safety.
• Deep understanding of GxP and ALCOA+ principles with the ability to embed quality and data integrity expectations into system and process design.
• Ability to identify, assess, and mitigate risks to issue resolution, timelines, scope, compliance outcomes, or deliverables, and to escalate appropriately.
• Ability to build and strengthen trust-based, collaborative relationships across diverse stakeholders, including global Quality, Supply Chain, Technical Ops, IT, and clinical development organizations.
• Strong strategic thinking and decision-making, with the ability to interpret data, assess trends, and drive systemic improvements.
• Excellent communication skills, with the ability to convey complex information clearly, persuasively, and tactfully across all organizational levels.
• Ability to lead global investigations and CAPA governance, ensuring strong root cause analysis and effectiveness evaluation aligned with QRM expectations.
• Adaptability
• Clinical Trials Operations
• Collaborative Development
• Compliance Strategies
• Cross-Functional Leadership
• Decision Making
• Documentations
• GMP Compliance
• Leadership
• Performance Monitoring
• Process Improvements
• Project Governance
• Project Planning
• Regulatory Compliance
• Resource Allocation
• Results-Oriented
• Risk Management
• Safety Management
• Strategic Planning
• Strategic Thinking
• Technical Quality Assurance
• Time Management

Nice To Haves

• Quality Risk Management (QRM) expertise for application to investigations, change control, and system design.
• Leadership of Communities of Practice or global SME networks supporting system governance.
• Data and analytics proficiency (KPI development, trending, dashboards).
• Formal Change Management training or demonstrated skill in leading cross‑functional change.
• Experience with GMP electronic systems (e.g., MEDs, Veeva, TrackWise, LMS).
• Lean Six Sigma experience or equivalent continuous improvement capability.
• Change Management
• Continuous Improvement
• Quality Management Systems (QMS)
• Standard Operating Procedure (SOP) Review

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees