Job Details

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.

McKesson is seeking a Manager, Investigations.

The Manager, Investigations will serve as a member of the Product Safety Review Team and work on investigations related to notifications of suspect product for McKesson’s U.S. Pharmaceutical Solutions & Services (PSaS) distribution businesses, located in Las Colinas, Texas (near Dallas). The Manager will report directly to the Director Operations Quality (within McKesson PSaS Quality Organization). The Manager will be responsible for conducting suspect product investigations, making determinations of illegitimate product, appropriately documenting investigations, and filing applicable documents with external regulators.

Additionally, the Manager will provide support to the Director in ensuring that McKesson’s PSaS distribution network operates in accordance with internal policies and procedures and relevant state laws and regulations, with a focus on DEA and state-equivalent agencies responsible for enforcement of requirements regarding controlled substances and listed chemicals.

The ideal candidate will have experience in the health care and/or drug distribution industry, with a background in conducting internal investigations or performing audits.  He or she will have broad familiarity with the laws and regulations governing the activities of pharmaceutical manufacturers and distributors, health care providers, pharmacies, and other market participants, as well as the demonstrated ability to collaborate effectively with large teams consisting of business, legal, compliance, audit, and HR colleagues in a highly-matrixed environment. 

Key Responsibilities

• Initiate and conduct investigations into suspect product notifications, including adhering to required timelines from discovery/notification to investigation initiation to filing necessary documents with external regulators; assess any linkage to other notifications and/or investigations.

• Support development and implementation of policies and procedures related to regulated activities in the distribution centers, including those related to FDA and DEA requirements, among others.

• Manage communications from McKesson’s U.S. distribution centers to partners, manufacturers, and customers.

• Initiate notifications to McKesson’s U.S. distribution centers with clear guidance with respect to handling suspect and illegitimate product.

• Direct coordination of suspect product investigations with other internal teams and personnel, including but not necessarily limited to McKesson’s Global Security and Safety team, and Distribution Regulatory Support Team.

• Document, update, and maintain investigation reports in a timely manner.

• In accordance with internal SOPs, lead process for closing investigations and filing necessary documents with U.S. FDA and other external regulatory bodies.

• Follow defined process to obtain necessary approvals for completed investigations.

• Manage document record retention requirements in accordance with internal SOPs.

• Establish effective partnerships across the business, such as Internal Audit, Legal, Operations, Global Security and Safety, Distribution Regulatory Support, Product Management and Purchasing.

• Ensure compliance with policies and relevant federal and state laws and regulations.

Minimum Requirements

Degree or equivalent and typically requires 4+ years of relevant experience

Critical Skills 

• 5+ years of experience in quality, regulatory, compliance, legal, business, or related field.

• Corporate/Internal Investigations experience; internal audit experience; fraud & abuse and/or compliance & ethics background.

• Ability to conduct complex initiatives in a self-directed manner, with minimal oversight, and to deliver superior results in a timely manner.

• Must have excellent written and verbal communication skills to effectively communicate with a broad spectrum of business segment personnel and senior management.

• Excellent prioritization skills to manage multiple, ongoing initiatives as may be required in a changing business environment.

• A superior level of professionalism to work effectively with internal and external personnel and promote the reputation and integrity of the General Counsel Organization.

• Excellent decision making and judgment capability.

• Experience working with sensitive information and can maintain confidentiality.

• Highly organized with meticulous attention to detail.

• Strong analytical and organizational skills as well as problem-solving capabilities.

Additional Knowledge & Skills

• Experience with FDA regulations and rules, including the Drug Supply Chain Security Act (DSCSA).

• Experience with DEA regulations and rules, including the Controlled Substances Act (CSA)

• Compliance auditing and monitoring skills a plus.

• Experience working in a large, matrixed institutional setting preferred but not required.

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to supportphysical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, pleaseclick here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. 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

McKesson is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

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 Disability_Accommodation@McKesson.com. Resumes or CVs submitted to this email box will not be accepted.

Current employees must apply through the internal career site.

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