Manager, Investigations @ McKesson

Job Information

Job Description:

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.

Company Information

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