QA Compliance Specialist - Controlled Substances

Operations Specialist - Controlled Substances

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.

The Operations Specialist - Controlled Substances oversees quality and compliance activities related to the storage, handling, and distribution of controlled substances within Distribution Centers. The role ensures compliance with federal and state-controlled substance regulations through cross-functional collaboration, leadership, decision-making, training, and issue resolution, often without onsite supervision.

Key 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 all applicable laws, regulations, and procedures.
• Lead or approve controlled substance nonconformance investigations, track KPIs, 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 (e.g., DEA) for inspections and regulatory inquiries.

Minimum Job Qualifications:

• Bachelor's degree in a relevant field such as science, healthcare, quality/compliance, supply chain, or distribution operations required. Advanced degree preferred.
• Minimum of 5 years of experience in Quality Assurance, compliance, regulatory affairs or regulated distribution operations.
• Minimum of 3 years of leadership experience, including direct people leadership, project leadership, or cross-functional process ownership.
• Experience supporting regulated warehousing or distribution operations, including inventory control, investigations, audits, training, and quality system documentation.
• Experience with pharmaceutical distribution, controlled substance compliance, and inspections by regulatory agencies such as DEA, FDA, or State Boards of Pharmacy preferred.

Specialized Knowledge/Skills

• Thorough knowledge of federal controlled substances regulations (21 CFR Title 21, Chapter II, Parts 1300+)
• Knowledge of applicable state-controlled substance laws preferred
• Strong knowledge of 21 CFR 210, 211, and 820; ISO 13485
• Proven leadership, interpersonal, influence, and negotiation skills
• Strong analytical and problem-solving abilities
• Excellent written and verbal communication skills across organizational levels
• Ability to use AI-enabled tools and analytics to support controlled substance compliance monitoring, inventory anomaly detection, investigation trending, and KPI reporting, while ensuring all outputs are appropriately reviewed, validated, and compliant with regulatory, audit, and data integrity requirements.

Working Conditions:

• Distribution Center environment
• Onsite role with locations in Kansas City, MO and Columbus, OH

Travel Requirements:

• Willingness to travel as necessary

About MMS

McKesson Medical-Surgical (MMS), which is expected to become Wellverse in early 2027, is a subsidiary and publicly reported segment of the McKesson Corporation. MMS distributes medical-surgical supplies, pharmaceuticals, diagnostic equipment and supplies, along with other solutions and services to virtually every type of healthcare setting and provider outside of the traditional hospital. These markets often referred to as Alternate Care or Non-Acute Care include physician offices, surgery centers, long-term care providers, laboratories, home health and hospice agencies, health systems, government facilities and online marketplaces and retailers.

Alternate Care markets are growing rapidly, and MMS is proud to be a leader in this space. With a team of approximately 8,000 employees, a network of 15 distribution centers and approximately 900 delivery vehicles, we collaborate with more than 2,200 leading manufacturers and serve over 200,000 customer accounts across the U.S. Our catalog includes more than 270,000 SKUs of branded and private-label medical-surgical products from bandages to specialty pharmaceuticals and COVID-19 tests.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Our Base Pay Range for this position

$83,300 - $138,800

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) Disability_Accommodation@McKesson.com or (Canada) Accessibility@mckesson.ca.

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