The SeniorManager, Investigations, Compliance & Ethics ("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 distribution businesses, located in Las Colinas, Texas (near Dallas). The Senior Manager will report directly to the Director, Compliance & Ethics (within McKesson's General Counsel 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.
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.
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.
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 McKesson's Global Security and Safety team, Distribution Regulatory Support Team, and Quality Operations.
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.
Followed 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, Quality Operations, Global Security and Safety, Distribution Regulatory Support, Product Management and Purchasing.
Ensure compliance with policies and relevant federal and state laws and regulations.
7+ years' experience in compliance, legal, business or related field.
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).
Compliance auditing and monitoring skills a plus.
Experience working in a large, matrixed institutional setting preferred but not required.
An outstanding record of academic achievement, including an undergraduate degree (required).
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 McKessonTalentAcquisition@mckesson.com . Resumes or CVs submitted to this email box will not be accepted.
Current employees must apply through the internal career site.
Join us at McKesson!
Internal Number: JR0040344
About McKesson Corporation
We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to provide you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight-year-old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of healthcare. If you are passionate about combining a meaningful career with a balanced life, join us on this journey and apply for a job with McKesson today. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient.