Supply Operations Quality Lead
Listed on 2026-08-02
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
• Provide end-to-end quality oversight for U.S. distribution operations, including warehousing, transportation, and cold chain activities.
• Serve as the senior quality authority for assigned logistics and distribution sites, using sound, risk-based judgment to support compliant and efficient operations.
• Lead regulatory, internal, and customer inspection readiness activities, including preparation, hosting, response strategy, and remediation.
• Drive effective governance of deviations, CAPAs, change controls, audits, and other quality system processes.
• Partner with stakeholders across Supply Chain, Regulatory, Market Quality, Security, and commercial teams to resolve complex quality issues and protect product supply.
• Use quality metrics, trends, and operational insights to identify risks, improve processes, and strengthen overall system performance.
• Lead and develop colleagues by building capability, strengthening quality culture, and supporting succession planning and organizational growth.
- BA/BS with 6+ years of experience in scientific, technical, or related discipline, or MBA/MS with 5+ years of experience, or PhD/JD with 1+ year of experience, or MD/DVM with any years of relevant experience
- Significant experience in pharmaceutical quality, supply chain, manufacturing, distribution, or another highly regulated environment.
- Strong knowledge of GMP and GDP requirements as they apply to logistics, storage, transportation, and product quality.
- Demonstrated experience supporting or leading regulatory inspections and audits, including preparation and follow-through.
- Proven ability to lead teams, coach colleagues, and build organizational capability.
- Strong decision-making, communication, and cross-functional collaboration skills.
- Experience with quality systems and digital tools like SAP, Veeva Vault, and Microsoft Office 365.
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