Manager of Quality Management Systems

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The Manager, Quality Management Systems (QMS) is responsible for ensuring compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards within a warehouse environment supporting clinical trial supplies. This role leads the implementation, maintenance, and continuous improvement of quality systems to ensure regulatory compliance, operational excellence, and inspection readiness.

• Oversee and manage QMS processes, including document control, policy development, and procedure implementation, in alignment with GDP, 21 CFR, and industry standards.
• Plan, conduct, and manage internal and external audits of warehouse operations to ensure compliance with regulatory requirements, quality guidelines, and standard operating procedures (SOPs).
• Lead deviation management, including investigations, corrective and preventive actions (CAPAs), change control activities, and risk assessments.
• Ensure timely vendor and customer qualification and verification activities.
• Verify accuracy and completeness of quality documentation for all inbound and outbound transactions executed by warehouse operations.
• Maintain accurate, current, and compliant records within the electronic QMS (eQMS) for all quality-related documentation and activities.
• Review, approve, and authorize quality-related documents, records, and agreements.
• Prepare, review, and maintain SOPs, validation documentation, training records, and other quality documents within the eQMS to ensure compliance with regulatory and organizational standards.
• Support regulatory inspections, internal audits, and customer audits by providing documentation, addressing findings, and ensuring inspection readiness.
• Monitor QMS performance using metrics and reports to assess effectiveness and identify opportunities for improvement.
• Develop and deliver training programs for staff on QMS processes, GDP requirements, and regulatory compliance.
• Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory functions, to resolve quality issues and implement improvements.
• Train warehouse operations personnel on quality procedures and compliance expectations.
• Stay current with evolving regulatory requirements and ensure timely incorporation into QMS practices.
• Conduct annual reviews of SOPs and update processes as required.
• Ensure all quality and operational documents are maintained in a controlled, secure, and compliant manner.

• Minimum of 5 years of experience in a Quality Management Systems role within the pharmaceutical or life sciences industry.
• Results‑oriented professional with a strong customer service mindset and effective communication skills.
• Experience with SAP and electronic QMS platforms preferred.
• High attention to detail with professional verbal and written communication skills.
• Ability to manage multiple priorities and projects simultaneously in a regulated environment.
• Willingness and ability to travel for audits, meetings, and industry events.
• Strong time management, organizational, and problem‑solving skills.
• Self‑motivated, accountable, and proactive in driving quality initiatives.
• Proficient in administrative tools, including MS Office and Google Workspace.
• Excellent written, verbal, and interpersonal communication skills.

Masters is preferred.

• Associate

• Full‑time

• Science

• Staffing and Recruiting