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The Manager, Investigations ("Manager") will serve as a member of the Cold Chain and Product Safety Review Team. The role focuses on both temperature excursion evaluations and 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 Quality Assurance Director (within McKesson PSaS Quality Organization).The Manager will be responsible for temperature excursion evaluations and conducting suspect product investigations in collaboration with McKesson Trading Partners, appropriately documenting investigations.

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 FDA and state-equivalent agencies responsible for enforcement of requirements regarding the Drug Supply Chain Security Act (DSCSA).

The ideal candidate will have experience in the health care and/or drug distribution industry, with a background in conducting and competently documenting 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

• Responsible for monitoring reports of potential temperature excursions, initiating product evaluations, and determining the disposition of impacted products to ensure compliance with regulatory standards and maintain product integrity.
• Acts as the central point of contact and organizer for all excursion details, ensuring accurate and timely evaluations by communicating with internal and external partners to determine product disposition, while providing status updates to the Distribution Center (DC) and other key stakeholders.
• 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 Requirement

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

Education

An outstanding record of academic achievement, including an undergraduate degree (or equivalent experience).

Critical Skills

• 4+ 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.
• Has meticulous attention to detail, highly organized.
• 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.

Working Conditions

• Able to travel overnight domestically 10% of the time.
• Remote/Work at Home - Must live in proximity to a McKesson Distribution Center in one of the following states: AK, AL, AZ, CA, CO, FL, GA, IA, IL, MA, MI, MO, MS, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA & WA.

Must be authorized to work in the US unrestricted - This position is not eligible for sponsorship.

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. For more information regarding benefits at McKesson, pleaseclick here.

Our Base Pay Range for this position

McKesson is an Equal Opportunity Employer

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

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McKesson is an equal opportunity and affirmative action employer - minorities/females/veterans/persons with disabilities.