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MSD

Associate Director, Global Clinical Supply Compliance

MSD

Associate Director responsible for advancing GxP Quality Systems across Global Clinical Supply. Ensuring compliance and leading projects in a highly matrixed organization with 60+ countries involved.

Posted 6/25/2026full-timeRahway • New Jersey • 🇺🇸 United StatesSenior💰 $129,000 - $203,100 per yearWebsite

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • The Associate Director in Global Clinical Supply (GCS) Compliance is a subject matter expert and project leader responsible for advancing and sustaining GxP Quality Systems across GCS to ensure clinical supply operations are executed 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 (EHS).
  • This role applies deep technical judgment and systems level thinking to complex compliance challenges while influencing outcomes across a highly matrixed organization.
  • This role provides expert support and project leadership for key GCS compliance processes —including deviations, CAPA, change control, documentation, training, audits/inspections, analytics, risk management, and EHS.
  • Partners closely with GCS functional areas and stakeholders within Development Sciences and Clinical Supply, our company's 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.

Requirements

What you’ll need
  • Bachelor’s degree in a Scientific, Engineering, or related field with 8+ years of relevant experience in a regulated GxP environment; or master’s degree with 6+ years of experience in compliance, quality, technical operations, or related disciplines.
  • Demonstrated experience in supporting or managing multiple GxP Quality Systems (e.g., deviations, CAPA, change control, documentation, training, audits/inspections, risk management, EHS) is required.
  • Proven ability to lead cross-functional initiatives or complex compliance projects at a regional or global scale.
  • Experience and ability to provide technical oversight and strategic process leadership across multiple compliance pillars such as deviations, CAPA, change control, documentation, training, risk management, inspection/audit coordination, and Environmental Health & Safety.
  • Proven track record of interpreting regulations and designing new processes or governance frameworks to drive compliance across global network.
  • Advanced ability to apply GxP and ALCOA+ principles to ensure quality and data integrity in system and process execution.
  • Expertise in proactively identifying, assessing, and mitigating risks to timelines, scope, compliance outcomes, or deliverables, including high-level escalation and risk communication.
  • Proficiency in performing and overseeing complex investigations and CAPA activities with deep root cause identification and QRM-aligned rigor.
  • Ability to build and lead strong, trust‑based partnerships across Quality, Supply Chain, Technical Operations, IT, and clinical development stakeholders, enabling collaborative compliance strategies and performance improvement initiatives.
  • Exceptional analytical skills with demonstrated capability to interpret operational trends and support data‑driven decisions. Includes designing, implementing and optimizing data analytic tools or dashboards for actionable insights.
  • Excellent communication skills, supporting clear, concise, and influential interactions across functional and site teams. Includes effective presentations of compliance findings and recommendations to leadership and key stakeholders.

Benefits

Comp & perks
  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
GxP Quality SystemsdeviationsCAPAchange controldocumentationtrainingauditsinspectionsrisk managementEnvironmental Health & Safety
Soft Skills
leadershipanalytical skillscommunication skillscollaborationinfluencingstrategic thinkingproblem-solvingtrust-buildingproject managementdata-driven decision making