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 inspectionready and riskbased manner. GCS supports Phase IIV 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 companys 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:

• Bachelors degree in a Scientific Engineering or related field with 8 years of relevant experience in a regulated GxP environment; or masters 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 trustbased 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 datadriven 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 coleading 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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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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