McKesson Senior Director, Quality Systems in Memphis, Tennessee
McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. It starts with the chain of events you initiate when you work with McKesson Pharmaceutical - a chain that extends across the country and results in millions of people getting more from their healthcare.
As the leader in pharmaceutical distribution and supply chain management, McKesson Pharmaceutical delivers vital branded and generic pharmaceuticals, as well as over-the-counter products, to more than 40,000 customers in three primary segments: retail chains, independent retail pharmacies and institutional providers such as hospitals, health systems, integrated delivery networks and long-term care providers.
We base our distribution excellence on electronic order processing, asset management tools, a commitment to Six Sigma methodology, order accuracy and supply chain safety. We work with our customers on solutions - including supply management technology, world-class marketing programs, managed care and repackaging products and services - that help them meet their business and quality goals. Our entire team works to ensure patients receive their medications efficiently and begin the process of healing.
As the nation’s largest pharmaceutical distributor, US Pharmaceutical is committed to driving total pharmacy health for customers and ensuring that customers receive the right drug at the right time, every time. This commitment is underpinned by McKesson’s focus on providing customers with the industry’s highest product availability, intelligent ordering capabilities and unmatched service accuracy.
Join our team of leaders to begin a rewarding career.
The Sr. Director, Quality Systems will have the overall responsibility for quality systems in the McKesson Corporation packaging businesses which include a pharmaceutical packaging facility in Memphis, TN, and a virtual manufacturer business also located in Memphis, TN. The quality systems leader is responsible for building and leading successful quality units which include quality control, quality systems/assurance, laboratory, and validation functions within the organizations.
In this capacity, the Sr. Director, Quality Systems is responsible for both strategic direction and decisions of the Quality Department in collaboration with other McKesson teams, as well as directing daily activities as required by the business and team members. The role includes, but is not limited to the following activities:
Drives a continuously improving quality culture throughout the organization by establishment and execution of well-planned, annual strategic quality goals for the packaging organization
Monitors and communicates quality plan status/progress through monthly metrics, quarterly reports, and annual product reviews
Manages a Quality/Lab Department structure staffed with personnel that will ensure applicable regulatory compliance and align with business needs
Supports the creation and enforcement of applicable cGMP and GLP standard operating policies, procedures, and work instructions
Recruits, leads, and develops managers and supervisors to achieve business goals
Serves as host for regulatory body and customer inspections and is responsible for any follow-up activities and communication after regulatory compliance and / or legal review as applicable.
Escalates applicable incidents to the business unit leader, Legal, and Regulatory/Compliance as well as suppliers, customers when applicable, and regulatory bodies as appropriate and in conjunction with key McKesson team members.
Ensures systems are in place for appropriate evaluation, documentation, and follow-up for deviations, laboratory OOS investigations, change control, labeling, licensing, and other typical GMP quality system elements
Oversees supplier and service provider quality program, including quality agreements and audits
Overall responsible for stability laboratory which supports that all active products meet or exceed shelf-life dating
Provides work direction, prioritization, problem resolution, and deadlines as needed to ensure timely completion of work and responsiveness of Quality Unit
Responsible for and monitors Quality Unit budgets, including laboratory costs
Actively participates as member of senior leadership team within Packaging organization
10 years quality assurance or related experience and 7 years managerial experience
Extensive knowledge of cGMP practices and CFR 21 210-211 with a minimum of 5 years in a pharmaceutical cGMP environment
Working knowledge of GLP regulations
Working knowledge of DEA and state board of pharmacy regulations for re-packaging and distribution
Experience in pharmaceutical product FDA listing and labeling control
Demonstrated leadership ability
Additional Knowledge & Skills
10 Years managerial experience in pharmaceutical quality unit preferred
10 Years pharmaceutical manufacturing management experience preferred
Direct FDA interaction with hosting inspections preferred
Repackaging/Labeling experience a preferred
General Chemistry/Microbiology knowledge a plus
21 CFR Part 11/GAMP 5 knowledge a plus
4-year degree in related field
General Office Demands
Benefits & Company Statement
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 and affirmative action employer – minorities/females/veterans/persons with disabilities.
Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
No agencies please.
Job: Distribution Operations
Organization: McKesson Pharmaceutical
Title: Senior Director, Quality Systems
Requisition ID: 18004641