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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.

Job Summary:

The Manager, Quality Assurance & Regulatory Affairs is responsible for developing, applying, revising, and maintaining quality standards for the distribution of plasma. This position also designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment, analyzes reports and returned products, and then recommends and drives corrective action along with preparing documentation for inspection/testing procedures.

Key Responsibilities:

• Provides Quality Assurance and Regulatory Affairs oversight for all processes in the Erlanger, KY Facility.
• Oversee all Quality Assurance process, including but not limited to; product release processes, ensuring each product release process has been correctly followed by the quality team in the Erlanger Facility.
• Ensures that regulatory and operational requirements are defined, implemented and monitored at the DC. Follows defined process to monitor temperature of all product storage areas and to document excursions.
• Works with the training department to ensure that Operations and Transportation is maintaining training records for all associates and that all resources have been trained on key SOPs associated with their roles in Erlanger Facility.
• Serves as a training resource to ensure compliance to all regulations regarding cGMP, GHA, ISO, and plasma laws related to third party logistics and storage regulations.
• Assures that Quality Team logs/reports all relevant information on site processes, compliance and issues in the respective quality management systems.
• Leads non-conformance or CAPA investigations related to product and process quality. Creates reports documenting errors and compliances issues, and recommends potential solutions when appropriate.
• Regularly communicates with the site Operations and Transportation Team to escalate issues and to recognize individual and team compliance.
• Hosts client audits to ensure that the company is in compliance with client requirements and in compliance with cGMP and plasma regulations for all services provided. This also includes ISO and other external audits.
• Assists with validations of storage areas, systems, or equipment where required, assists Sr. Manager with special projects and development of new business processes.
• Communicates frequently with the site Quality Assurance Team, Transportation Team, and Operations Teams to communicate quality issues and successes and to explain/understand new requirements and regulations as they arise.
• Partners with Operations Team and Transportation Team to ensure that all quality goals and procedures are in place and working to meet FDA, ISO, GHA, and Client Contract Compliance.
• Partners with the Facilities, Operations, Transportation Management to ensure that the facility meets all temperature, security, and safety requirements.

Minimum Job Qualifications (Knowledge, Skills, & Abilities):

• Degree or equivalent experience. Typically has 6+ years of professional experience and 0-2 years' supervisory experience.
• Prior experience with mentoring and developing staff; committed to helping people succeed
• Proven ability to drive continuous improvement with fundamental understanding of change management
• Can provide honest feedback and respectfully challenge others
• Able to make difficult (sometimes unpopular) decisions when required
• Demonstrated passion aligned with McKesson's corporate vision, leading with the employee in mind
• Demonstrated ability to adapt communication skills to effectively influence different audiences
• Actively seeks opportunities to build and maintain relationships both in and out of business unit
• Demonstrated ability to prioritize and make decisions under pressure
• Knowledge of Microsoft: Outlook, Word, Excel and PowerPoint
• SAP experience a plus, but not required.

Working Conditions:

Environment (Office, warehouse, etc.) -

Traditional office requirements. Large percentage of time performing computer-based work is required. Must be authorized to work in the US. Sponsorship is not available for this position. Working conditions may include warehouse dock conditions that are 0- 5 Celsius, walking in and out of the warehouse to the office. Office conditions are 7-8 hours a day. In some cases, this position may require going into the freezer, -30 Celsius.

Physical Requirements (Lifting, standing, etc.) -

Ability to correctly input data into the computer. Able to communicate effectively with customers whether in person, on the telephone, or through correspondence. Ability to work alongside Operation's team member, which would include Shipping, Receiving, removing unit pulls.

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. 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 r ace, color, r eligion, s ex, s exual 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.