Associate Director, Global Clinical Supply Compliance (Hybrid)

Job Description

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).

In this role, the Associate Director 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. Associate Directors are expected to apply expertise and subject matter depth broadly across these domains.

The Associate Director 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.

Qualifications

Education & Experience:

• 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.

Skill-based Qualifications:

With strong subject matter expertise, sound judgment, and the ability to lead complex system and process design and execution, candidates must demonstrate:

• 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. Includes ability to independently resolve complex compliance challenges and deliver sustainable improvements.

• 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.

Preferred Experience and Skills:

• Working knowledge of Quality Risk Management (QRM) tools and concepts for application to investigations, change control, and system design.

• Experience contributing to or co‑leading Communities of Practice or SME networks.

• Experience supporting or leading Change Management activities (training, documentation updates, rollout planning).

• Experience with GMP electronic systems (e.g., MEDs, Veeva, TrackWise, LMS, SAP).

• Experience applying Lean Six Sigma or continuous improvement methodologies.

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Required Skills:

CAPA Management, Clinical Supply Chain Management,