Director, Global Clinical Supply Compliance

Job description

Job Description 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, Research Laboratories Quality Assurance, Global Development Quality, IT/Digital, GCTO, Procurement, and other enterprise stakeholders to drive compliance strategy, QMS alignment, and performance improvement within GCS. Qualifications Education & Experience: 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. Skill-based Qualifications: With strong independent judgment, advanced technical expertise, and the ability to lead enterprise-wide compliance systems, candidates must demonstrate: 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. Preferred Experience and Skills: 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. Required Skills: Compliance Strategies, GMP Compliance, Lean Six Sigma (LSS), Performance Monitoring, Process Improvements, Quality Risk Management, Regulatory Compliance, Risk Management, Safety Management, Six Sigma, Strategic Planning Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 08/13/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.