McKesson

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.

The Quality Manager, Production & Process Controls is responsible for the implementation and daily management of Quality Assurance (QA) activities at sites associated with special projects. The QM works closely with site ops leaders, associates and QA staff at each facility, to ensure Standard Operating Procedures (SOPs) are followed, production deliverables are met and the facility is in adherence to FDA QSR for medical devices (Title 21, part 820) and pharmaceutical GMP regulations (part 210 & part 211). This role will act as the site quality representative for all internal and external interfaces.

This working location for this role is Manteno, IL. This location is within commuting distance from Naperville, Bolingbrook, Orland Park and Plainfield. This is a 100% onsite role at the Manteno, IL facility with up to 25% travel as needed.. Relocation assistance may be provided per McKesson policy. This is a early career leadership role in a growing organization.

Key Responsibilities/ESSENTIAL FUNCTIONS

Responsible for developing, applying, revising, and maintaining quality standards for processing materials into partially finished or finished products. Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or processes. Analyzes reports and returned products, and recommends corrective action. Prepares documentation for inspection/testing procedures. Decisions & actions of AQM will impact the direct workgroup, and failures to achieve may impact short-term goals and deadlines of the department. 

Primary responsibility involves maintaining the QMS and trending of Production and Process Control data including product returns, non-conformances and manufacturing defects. The ideal candidate for the position will possess excellent verbal communication skills. Becoming proficient with MasterControl will facilitate the ability to quickly pull data as necessary for internal or potentially external audit reasons. 

• Maintains knowledge of domestic (FDA QSR, DSCSA, UDI) and international regulations (EU MDR, UK MHRA, TGA etc) and standards (ISO 13485, ISO 149710) as required per business needs
• Publishes reports documenting errors and compliances issues and recommends potential solutions when appropriate.
• Strong writing and communication skills; ability to communicate effectively both to internal stakeholders & colleagues as well as external Regulators
• Regularly communicates with the Operations team to escalate issues and to recognize individual and team compliance
• Independently work on problems of diverse scope where analysis of quality attributes & metrics requires evaluation of identifiable factors.
• Independently owns CAPAs from initiation to closure
• Responsible for resource utilization of site quality personnel
• Must have demonstrated experience in situations where the development of the solution requires a multi-disciplinary approach
• Upto 25% travel to support internal projects as required
• This individual must be flexible for supporting internal & external customers during extended hours
• Other duties as assigned

Responsibilities in order of importance 

Responsible for daily operations to ensure compliance to SOPs and Federal Regulations across assigned site

60 % of time

Travel to various facilities to support new business and/or quality events

25 % of time

Audit Readiness and Support (Internal and/or External)

10 % of time

Publish Regular Quality metrics (eg Production & Process Controls, Defects etc)

5 % of time

Qualifications for the Position

Education/Training

• Undergraduate degree required, STEM preferred
• At least 6 years of experience in quality with at least 3 years in drugs and/or device industry
• Working knowledge of the FDA regulations for Medical Devices (21 CFR 800 – 822)
• Experience with MasterControl or other computerized document control systems a plus
• Good working knowledge and understanding of cGMP, Quality Standards, Requirements, and Specifications (ISO, ANSI, FDA, etc).
• ASQ certification will be required within 6 months of hire

Business Experience

• Must have good organizational and communication skills
• Quality Assurance experience in the production of medical devices preferred
• Ability to work independently and make decisions based on judgement and integrity.
• Proven technical and problem solving skills in dealing with complex issues and the ability to transfer findings into report and presentation formats.
• Ability to work effectively with others to accomplish goals in a challenging environment
• Experience with Microsoft Word, Excel and PowerPoint required
• Must be able to effectively communicate in English (oral and written)

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. 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. 

Our Base Pay Range for this position

$87,500 - $145,800

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 Disability_Accommodation@McKesson.com. Resumes or CVs submitted to this email box will not be accepted.

Current employees must apply through the internal career site.

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