Sr. Director of Regulatory Affairs & Quality Assurance
Location: Louisville, Kentucky
Internal Number: JR0049706
McKesson requires new employees to be fully vaccinated for COVID-19 as defined by the CDC, subject to applicable, verified accommodation requests.
The state of healthcare is complex, but our shared purpose isn't: Help people get the medicine they need to live healthier lives. CoverMyMeds solves medication access challenges for patients throughout every step of their journey through a unified brand that now encompasses RelayHealth, RxCrossroads by McKesson, McKesson Prescription Automation and CoverMyMeds.
With our RxCrossroads Third Party Logistics (3PL) Services team, we help navigate the complex healthcare landscape while streamlining the path to commercialization with our fully integrated, best-in-class distribution solution. We offer everything you'd expect from a best-in-class 3PL solution from licensing to distribution and fulfillment - a true extension of the client team.
The RxCrossroads 3PL Services team is proud to be an integral part of McKesson Corporation and embody the shared values and leadership behaviors of the greater organization.
We understand the importance of a system that works together. Your expertise, drive and passion can help us carry out our mission to improve lives and advance healthcare.
The Senior Director, Quality and Regulatory Affairs (QRA) is principally responsible for the RxCrossroads Third Party Logistics (3PL) Service's quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, and compliance-related investigations. The Sr. Director of QRA will communicate updates and provide overall vision, strategy and support of quality assurance initiatives and regulatory affairs matters. The focus is on proactive management of quality assurance risks and preventive management as opposed to crisis management.
The Senior Director, QMS has responsibility for:
Implementing written policies, procedures, and standards of conduct
Maintaining a quality assurance committee
Developing effective lines of communication
Conducting periodic risk assessments and response plans
Conducting internal monitoring and auditing
Responding promptly on detected offenses, developing corrective action, and reporting findings to the VP, Quality and Regulatory Affairs
Attracting, retaining, and developing high performing teams
The Senior Director, QRA and his or her designees have the authority to review all documents and other information that are relevant to quality assurance and regulatory affairs activities. This enables the Senior Director, QRA the ability to review contracts and obligations (seeking the advice of legal counsel, where appropriate) that allow the Company to comply with all contracted obligations.
In addition, the Senior Director, QRA will be responsible for all internal audit reports and will work closely with key managers to identify trends inconsistent with policies, procedures and contractual obligations. The Senior Director, QRA should ascertain patterns that require a change in policy and forward these issues to the quality assurance committee to remedy the problem.
The Senior Director, QRA is also responsible for team development. S/He must attract, retain, grow, and lead a cohesive and effective quality assurance and training team that is respected by the organization at all levels which is vital to the Company's success.
Typical Minimum Experience
13+ years of relevant Quality Assurance and Regulatory experience
5+ years of management experience
4-year degree in business or related field or equivalent experience
Advanced degree a plus (MBA, MS)
Must be able to travel up to 30-40%
5 + years' experience working within Quality Assurance in a government regulated environment
Accreditation experience with ISO Standards or regulatory agencies
Must be able to work independently and to be able to make tough and difficult reports when necessary
Must be detail-oriented, well-organized self-starter with high energy and creativity and ability to adapt to change in a positive manner
Ability to effectively utilize reference materials
Excellent oral and written communication skills
Strategic problem solving and decision-making ability
Ability to effectively manage conflict
Computer proficiency in MS Office Suite including intermediate Excel
McKesson believes superior performance - individual and team - that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it's flexible enough to meet the different needs of our diverse employee population.
We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.
But we can't do it without you. Every single McKesson employee contributes to our mission--whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company--and of healthcare. At McKesson, you'll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that's vital to us all.
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.
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.