Director, Global Clinical Supply Compliance

ppJob 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. /ph3Qualifications /h3ulliEducation 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. /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 /h3ulliWith 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 security. /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 elevate 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 /h3ulliCompliance Strategies, GMP Compliance, Lean Six Sigma (LSS), Performance Monitoring, Process Improvements, Quality Risk Management, Regulatory Compliance, Risk Management, Safety Management, Six Sigma, Strategic Planning /li /ulh3Preferred Skills /h3pMerck 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. /ph3Employee Status /h3pRegular /ph3Relocation /h3pNo relocation /ph3VISA Sponsorship /h3pNo /ph3Travel Requirements /h3p10% Flexible Work Arrangements: Hybrid Shift: Not Indicated /ph3Valid Driving License /h3pNo /ph3Hazardous Material(s) /h3pN/A /ph3Job Posting End Date /h3p08/13/2026 *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. /ph3Company Overview /h3pOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. /p /p #J-18808-Ljbffr