Director, Global Clinical Supply Compliance

Darum lohnt es sich

Directors are expected to lead broadly across these domains and apply deeper expertise where their strengths align. /ppThe 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. /ph3Qualifications /h3h3Education Experience /h3ulliBachelor’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. /liliExperience leading or governing multiple GxP Quality Systems (e.g., deviations, CAPA, change control, documentation, training, audits/inspections, risk management, safety) is required. /liliDemonstrated experience influencing cross‑functional teams across global or multi‑site organizations. /li /ulh3Skill‑based Qualifications /h3pWith strong independent judgment, advanced technical expertise, and the ability to lead enterprise‑wide compliance systems, candidates must demonstrate /pulliAbility to provide strategic oversight and governance for GxP processes across deviations, CAPA, change control, documentation, training, risk management, and safety. /liliDeep understanding of GxP and ALCOA+ principles with the ability to embed quality and data integrity expectations into system and process design. /liliAbility to identify, assess, and mitigate risks to issue resolution, timelines, scope, compliance outcomes, or deliverables, and to escalate appropriately. /liliAbility to build and strengthen trust‑based, collaborative relationships across diverse stakeholders, including global Quality, Supply Chain, Technical Ops, IT, and clinical development organizations. /liliStrong strategic thinking and decision‑making, with the ability to interpret data, assess trends, and drive systemic improvements. /liliExcellent communication skills, with the ability to convey complex information clearly, persuasively, and tactfully across all organizational levels. /liliAbility to lead global investigations and CAPA governance, ensuring strong root cause analysis and effectiveness evaluation aligned with QRM expectations. /li /ulh3Preferred Experience And Skills /h3ulliQuality Risk Management (QRM) expertise for application to investigations, change control, and system design. /liliLeadership of Communities of Practice or global SME networks supporting system governance. /liliData and analytics proficiency (KPI development, trending, dashboards). /liliFormal Change Management training or demonstrated skill in leading cross‑functional change. /liliExperience with GMP electronic systems (e.g., MEDs, Veeva, TrackWise, LMS). /liliLean Six Sigma experience or equivalent continuous improvement capability. /li /ulh3Required Skills /h3pCompliance Strategies, GMP Compliance, Lean Six Sigma (LSS), Performance Monitoring, Process Improvements, Quality Risk Management, Regulatory Compliance, Risk Management, Safety Management, Six Sigma, Strategic Planning /ph3Preferred Skills /h3h3Search Firm Representatives Please Read Carefully /h3pMerck Co., Inc., Rahway, NJ, USA, also known as Merck Sharp Dohme LLC, Rahway, NJ, USA /ph3Employee Status /h3pRegular /ph3Relocation /h3pNo relocation /ph3VISA Sponsorship /h3pNo /ph3Travel Requirements /h3p10% /ph3Flexible Work Arrangements /h3pHybrid /ph3Shift /h3pNot Indicated /ph3Valid Driving License /h3pNo /ph3Hazardous Material(s) /h3pN/A /ph3Job Posting End Date /h3ulliA job posting is effective until PM on the day BEFORE the listed job posting end date. ph3Job Description /h3pThe 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. /ppThis 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.

Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. /li /ulpbRequisition ID /b R /p /p