McKesson

Operations Specialist - Controlled Substances

McKesson$83K — $138K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a related field; advanced degree preferred.
  • 5+ years in Quality Assurance, compliance, or regulated distribution operations needed.
  • 3+ years of leadership experience, including project or people leadership.
  • Experience in regulated warehousing and quality control processes required.
  • Preferred background in pharmaceutical distribution and inspections by regulatory agencies.

Responsibilities

  • Manage quality systems for controlled substances storage and distribution.
  • Ensure compliance with inventory control and reporting procedures.
  • Collaborate with Operations to maintain regulatory compliance.
  • Lead investigations into controlled substance nonconformance.
  • Prepare for inspections and conduct compliance training.
  • Act as liaison with regulatory agencies for all inspections.

Benefits

  • Onsite role located in Kansas City, MO and Columbus, OH.
  • Travel required as necessary.
  • Opportunity for leadership in a compliance-focused environment.
Full Job Description

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 throughcrossfunctionalcollaboration, leadership,decisionmaking, 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 managedaytodaydistribution 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 supportadditionaldistribution centers as needed.

  • Leadinspectionreadiness 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:

  • Bachelors 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 andproblemsolvingabilities

  • Excellent written and verbal communication skills across organizational levels

  • Ability to useAIenabledtools 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,MOand Columbus, OH

Travel Requirements:

  • Willingness to travel as necessary

(This description is general in nature and is not intended to be an exhaustive list of all responsibilities.Other duties may be assigned as needed to meet companygoals.)

About McKesson

McKesson Corporation provides medicines, pharmaceutical supplies, information and care management products and services across the healthcare industry. The Company operates in two segments. The McKesson Distribution Solutions segment delivers ethical drugs, medical-surgical supplies and equipment and health and beauty care products throughout North America. This segment also provides specialty pharmaceutical solutions for biotech and pharmaceutical manufacturers, sells financial, operational and clinical solutions for pharmacies (retail, hospital, long-term care) and provides consulting, outsourcing and other services. The McKesson Technology Solutions segment delivers enterprise-wide clinical, patient care, financial, supply chain, strategic management and software solutions. In July 2011, the Company acquired Portico Systems from Safeguard Scientifics, Inc. On March 25, 2012, it acquired the independent banner and franchise businesses of Katz Group Canada Inc. McKesson Distribution Solutions delivers pharmaceuticals to retail pharmacies and institutional providers like hospitals and health systems. They operate pharmaceutical distribution centers across the country, serving customers in all 50 states. They also deliver a comprehensive offering of health care products, technology, equipment and related services to the alternate site market, including physician offices, surgery centers, long-term care facilities and home care businesses across the country. McKesson is currently the largest pharmaceutical distributor in North America. McKesson also operates McKesson Canada and has an equity holding in Nadro, a leading distributor in Mexico.

McKesson Careers

Join McKesson, a leading global healthcare company, and be part of a team that is redefining the future of healthcare. With a variety of job opportunities available, McKesson is the perfect place to advance your career, whether you're a seasoned professional or just starting out. Work You’ll Do At McKesson, we are committed to improving care in every setting—one product, one partner, one patient at a time. We’re seeking talented professionals to join our team and contribute to a culture of innovation, diversity, and leadership. Our employees are driven by a deep sense of purpose and a desire for continuous growth and improvement. Empower Your Future in Healthcare With positions ranging from internships to leadership roles, McKesson offers unparalleled employment opportunities to develop your skills and advance your career. Our commitment to diversity training ensures that all team members have the opportunity to thrive. Join a team where your skills will be honed, your professional growth will be supported, and where you can genuinely see the difference you make in the lives of patients around the world. Innovative Work Environment McKesson is at the forefront of healthcare innovation. Our team is constantly exploring new ways to improve patient outcomes and streamline care processes. This commitment to innovation is what sets us apart and what makes McKesson an exciting place to work. Career Development and Benefits McKesson believes in nurturing the potential of its employees through robust career development programs and comprehensive benefits designed to support your life and well-being. From leadership training to health and wellness benefits, we ensure our team members are equipped to meet their professional and personal goals. Explore Job Opportunities Whether you’re looking for an internship to kickstart your career, or a senior position to utilize your extensive experience, McKesson offers a range of opportunities. Explore our open positions and find where you can make a difference at McKesson. Stay Connected Join Our Team Search for open positions that match your skills and interests. We are looking for passionate, curious, and solution-driven team players who are ready to take the next step in their careers. Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Networking and Professional Growth At McKesson, networking and professional growth are part of our everyday environment. We encourage our employees to connect, share, and learn from each other to foster personal and professional development. Job Alert Emails Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await you at McKesson. Join McKesson today and be part of a team that is dedicated to shaping the future of healthcare.
Learn more about McKesson
Size
58,000 employees
Market Cap
$53.7 billion
Industry
Net Income
-$4.1 billion
Founded
1833
5 Year Trend
+5.9%
Revenue
$237.6 billion
NASDAQ

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