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A growing organization within the pharma /healthcare warehousing space is seeking a hands-on Quality Assurance Manager to lead quality, regulatory, and safety programs across regulated warehousing, fulfillment, and production environments supporting healthcare and consumer clients. This role partners closely with executive leadership and operations to ensure regulatory compliance, audit readiness, and scalable quality systems while balancing business needs with regulatory requirements.
Job Responsibility:
Lead enterprise-wide Quality Assurance and Compliance programs
Ensure compliance with FDA, DEA, OSHA, cGMP, and client-specific requirements
Own client, regulatory, and internal audits from preparation through resolution
Manage CAPA programs, investigations, and effectiveness reviews
Oversee temperature-controlled operations, excursion management, and validation
Ensure inventory integrity, traceability, lot control, and recall readiness
Maintain licenses, certifications, and audit readiness
Drive SOP governance, document control, and training compliance
Lead warehouse safety and compliance initiatives
Partner cross-functionally to identify and mitigate operational risk
Promote a collaborative, solutions-oriented quality culture
Requirements:
5+ years of QA/Compliance leadership experience
Background in pharmaceutical, regulated warehousing, healthcare, or similarly regulated environments
Strong working knowledge of FDA, DEA, OSHA, cGMP, audits, and CAPA
Experience leading client and regulatory audits
Ability to influence cross-functionally in a hands-on, independent role
Nice to have:
Experience with inventory controls and warehouse systems