Associate Director, Global Clinical Supply Compliance

Role Overview

• 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

• 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.

Tech Stack

• Google Cloud Platform

Benefits

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