Senior Manager, Investigations

Senior Manager, Investigations

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 Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments, and other organizations in healthcare to help provide the right medicines, medical products, and healthcare services to the right patients at the right time, safely and cost-effectively.

United by our I2CARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful - all for the better health of patients. McKesson has been named a "Most Admired Company" in the healthcare wholesaler category by FORTUNE, a "Best Place to Work" by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more info, visit www.mckesson.com.

We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us.

McKesson is seeking a Senior Manager, Investigations.

The Senior Manager, Investigations ("Senior Manager") 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 Senior Manager will report directly to the Director Operations Quality (within McKesson PSaS Quality Organization). The Senior 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 Senior 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 healthcare and/or drug distribution industry, with a background in conducting internal product quality investigations or performing audits. He or she will have broad familiarity with the laws and regulations governing the activities of pharmaceutical manufacturers and distributors, healthcare 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.

Education & Minimum Requirements

• An outstanding record of academic achievement, including an undergraduate degree (or equivalent experience).
• Degree or equivalent and typically requires 7+ years of relevant experience.

Critical Skills

• 7+ 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.
• 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).

Additional Knowledge & Skills

• 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 in a changing business environment.
• A superior level of professionalism to work effectively with internal and external personnel.
• 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.
• 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, please visit our Equal Employment Opportunity page.

Our Base Pay Range for this position $105,500 - $175,900

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.