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McKesson

Supplies medicines and technology to healthcare teams

QA Compliance Specialist - Controlled Substances

Regulatory Compliance & EthicsConfirmed live in the last 24 hours
Full-timeIn-person

About the Job

Requirements

  • A bachelor's degree in a relevant field such as science, healthcare, quality/compliance, supply chain, or distribution operations is required.
  • At least 5 years of experience in Quality Assurance, compliance, regulatory affairs, or regulated distribution operations is required.
  • At least 3 years of leadership experience, including direct people leadership, project leadership, or cross-functional process ownership, is required.
  • Experience supporting regulated warehousing or distribution operations, including inventory control, investigations, audits, training, and quality system documentation, is required.
  • Thorough knowledge of federal controlled substances regulations (21 CFR Title 21, Chapter II, Parts 1300+).
  • Strong knowledge of 21 CFR 210, 211, and 820, and ISO 13485.
  • Ability to use artificial intelligence-enabled tools and analytics for controlled substance compliance monitoring, inventory anomaly detection, investigation trending, and key performance indicator reporting, while ensuring outputs are reviewed, validated, and compliant with regulatory, audit, and data integrity requirements.
  • Willingness to travel as necessary.

Responsibilities

  • Manage site quality systems and processes related to the storage, handling, and distribution of controlled substances.
  • Ensure policies and procedures are in place for inventory control, documentation, reporting, investigations, training, and audits related to controlled substances.
  • Partner with Operations to manage day-to-day distribution center activities and ensure compliance with applicable laws, regulations, and procedures.
  • Lead or approve controlled substance nonconformance investigations, track key performance indicators, drive continuous improvement initiatives, and support additional distribution centers as needed.
  • Lead inspection-readiness initiatives, including mock audits and compliance training.
  • Serve as the primary interface with regulatory agencies, such as the DEA, for inspections and regulatory inquiries.

Desired Qualifications

  • An advanced degree is preferred.
  • Experience with pharmaceutical distribution, controlled substance compliance, and inspections by regulatory agencies such as the DEA, FDA, or State Boards of Pharmacy is preferred.
  • Knowledge of applicable state-controlled substance laws is preferred.

About the Company

McKesson

Supplies medicines and technology to healthcare teams

McKesson distributes medicines and medical supplies to pharmacies, hospitals and other care providers, alongside services that connect drug manufacturers with patients. Its specialty businesses support community cancer care and clinical research, extending its work beyond moving products through warehouses. The company buys drugs and supplies from manufacturers for resale, while its software helps pharmacies manage inventory and healthcare teams secure insurance approval for prescriptions. It also sells practice management and patient support services to clinicians and drugmakers. McKesson traces its business roots to 1833 and is headquartered in Irving, Texas.

Company size
10,001+
Company stage
IPO
Headquarters
Irving, TX
Founded
1833

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