Quality Audit Manager

McKessonShepherdsville, KY
8d$77,000 - $128,300

About The Position

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. Summary of Purpose: The Quality Audit Manager oversees compliance with all applicable standards and client, regulatory, and organizational requirements across the Kentucky and Ohio 3PL facilities. The role is responsible for evaluating processes and outputs, identifying gaps, and recommending improvements to procedures and workflows.

Requirements

  • Two-year associates degree and/or equivalent experience.
  • Typically requires 1-3 years of relevant quality auditing experience.
  • Ability to communicate clearly and effectively, both verbally and in writing.
  • Strong attention to detail with the ability to enter data accurately and manage multiple tasks simultaneously.
  • Proficient in word processing, database, and spreadsheet applications, preferably within the Microsoft Office suite.
  • Must be able to work independently with minimal supervision while collaborating effectively with internal departments to achieve objectives and meet established deadlines.
  • Should be personable, self‑motivated, and maintain a positive attitude, with the ability to interact professionally with supervisors, colleagues, customers, and potential clients both in person and over the phone.
  • May sit, stand, stoop, bend, and walk intermittently during the day.
  • Must have the ability to life up to twenty-five (25) pounds, on occasion.
  • Ability to travel between product storage facilities within Kentucky and Ohio, as needed. As well as to supplier sites, as needed.

Nice To Haves

  • Certified Quality Auditor preferred.
  • 3-5 years in a pharmaceutical quality/regulatory environment preferred.

Responsibilities

  • Leads the development and coordination of internal and supplier audit programs, including creating comprehensive audit plans and maintaining audit schedules.
  • Conducts audits of operational and quality system processes to verify compliance with applicable regulatory, client, and internal requirements in accordance with established audit plans.
  • Oversees external audits to ensure organizational compliance with client expectations, FDA regulations, ISO 9001 standards, and other applicable external or supplier audit requirements.
  • Partners with departmental leaders to develop effective corrective actions and responses addressing observations and findings from both internal and external audits.
  • Submits audit responses to external auditors in accordance with the required formats and defined procedures.
  • Prepares, analyzes, and presents audit reports to senior leadership to support management review and continual improvement activities.
  • Other duties and responsibilities as assigned by manager.
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