QA Compliance Specialist Controlled Substances
Job Location:
Kansas City, KS - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 tomorrows health today we want to hear from you.
The QA Compliance 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 leadershipdecisionmaking 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 reviewedvalidated and compliant with regulatory audit and data integrity requirements.
Working Conditions:
Distribution Center environment
Onsite role with locations in Kansas CityMOand 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 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 8000 employees a network of 15 distribution centers and approximately 900 delivery vehicles we collaborate with more than 2200 leading manufacturers and serve over 200000 customer accounts across the U.S. Our catalog includes more than 270000 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 McKessons 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. For more information regarding benefits at McKesson pleaseclick here.
Our Base Pay Range for this position
$83300 - $138800McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKessons (or affiliated entities like CoverMyMeds or RxCrossroads) name in fraudulent emails job postings or social media light of these scams please bear the following in mind:
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
McKesson job postings are posted on our career site: .
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 McKessons 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) or (Canada) . Resumes or CVs submitted to this email box will not be accepted.
Join us at McKesson!
Required Experience:
IC
About Company
McKesson is the leading healthcare company for wholesale medical supplies & equipment, pharmaceutical distribution, and healthcare technology solutions. McKesson is the central nervous system of health care. At any given moment, in any given minute, we simultaneously execute thousands ... View more
