Supply Chain Business Support (SCBS) Group Lead

ROLE SUMMARY

Global Clinical Supply ensures that patients receive the investigational medicines precisely when they need them. By embracing challenges, imagining what’s possible, and taking decisive action, you will help accelerate the delivery of medicines to the world. The Supply Chain Business Support (SCBS) Group Lead provides global operational, quality, and governance leadership for Global Clinical Supply (GCS) business‑critical systems within Clinical Supply Informatics & Technology (CSIT).

This role serves as the primary business authority and escalation owner for validated clinical supply platforms, ensuring business continuity, inspection readiness, and regulatory compliance across a complex, GxP‑regulated environment.

The SCBS Group Lead is a senior operational partner to the Head of CSIT, translating strategic direction into executable priorities, leading cross‑functional incident response, and shaping decisions related to system risk, investment trade‑offs, and operational readiness that directly impact clinical trial execution and patient supply.

ROLE RESPONSIBILITIES

• Lead the global SCBS organization, accountable for the reliability, compliance, and operational performance of clinical supply systems supporting Global Clinical Supply.
• Serve as the single business escalation owner for high‑impact system, data, and process issues, directing triage, decision‑making, and resolution during planned and unplanned events, including releases, outages, and vendor incidents.
• Own business continuity and operational readiness, ensuring validated systems remain fit for purpose through upgrades, migrations, and Digital‑led changes, with clear risk assessment and mitigation strategies.
• Provide quality and inspection leadership, partnering with Quality to ensure deviations, CAPAs, commitments, validation artifacts, and audit responses are complete, accurate, and inspection‑ready.
• Act as the accountable business authority in cross‑functional forums with Digital, Quality, Regulatory, and external vendors, ensuring business requirements, validation expectations, and compliance risks are understood and addressed.
• Translate CSIT leadership direction into execution, including defining go-forward solutions, establishing governance and tracking mechanisms, and preparing executive‑ready summaries, risk assessments, and recommendations.
• Represent SCBS within CSIT leadership, contributing to operational reviews, metrics, planning, engagement actions, and leadership decision‑making forums.
• Drive continuous improvement across SCBS processes, metrics, and system usage to improve efficiency, compliance, and user experience, informed by incident trends and inspection feedback.
• Provide people leadership especially during high‑pressure operational events, coaching leaders, setting priorities, and maintaining clarity, accountability, and psychological safety across the team.

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 8 years of experience or MBA/MS with at least 7 years of experience or PhD/JD with at least 5 years of experience or MD/DVM with at least 4 years of experience in clinical supply, clinical operations, informatics, supply chain, or other regulated life‑sciences environments.
• 5+ years of experience leading teams or major operational functions within a GxP‑regulated environment.
• Demonstrated accountability for business‑critical systems or processes, including ownership of operational risk, issue escalation, and continuity planning.
• Proven experience partnering with Quality organizations to support deviations, CAPAs, validation activities, and inspection readiness.
• Strong understanding of data integrity principles, system validation, and quality system interactions in regulated environments.
• Demonstrated ability to lead cross‑functional decision‑making involving Digital/IT, Quality, Regulatory, Operations, and external vendors.
• Proven capability to communicate complex technical and operational topics clearly to senior leaders and executive stakeholders.

Bonus Points If You Have (Preferred Requirements)

• Advanced degree (e.g., Master’s, MBA, or equivalent experience).
• Experience serving as business owner or accountable escalation lead for enterprise clinical supply platforms (e.g., IRT ecosystems, Dynamics 365 / EMD365, CSDS).
• Demonstrated leadership during high‑impact operational events, including system outages, data integrity issues, or regulatory‑sensitive incidents.
• Experience participating in or leading regulatory inspections or internal audits, including direct interaction with inspectors or auditors.
• Proven ability to translate operational risk and technical complexity into executive‑ready recommendatio