Position Details

Salary $108K – $181K USD / year

Type Not Specified

Experience lead

Exp. Years 10+ years

Education Bachelor's degree in science or engineering

Category Healthcare & Medical

About this role

Sr Manager, Enterprise Quality Engineering leads enterprise-wide quality programs, focusing on climate control and regulatory alignment in a healthcare & medical environment.

Key Responsibilities

Oversee climate control and product storage strategies
Develop standards for climate control programs
Lead training on storage and QA programs
Drive continuous improvement for climate control and monitoring
Mentor teams across McKesson

Technical Overview

Emphasizes regulatory frameworks (FDA/ISO/EMA/BOP), climate control/audit programs, and data-driven quality improvement in a matrixed organization; leadership and training responsibilities are key.

Ideal Candidate

The ideal candidate is a senior quality leader with 10+ years in FDA-regulated environments, specializing in climate control and regulatory alignment across multiple sites, capable of driving digital transformation.

Must-Have Skills

10+ years of Quality experiencepharmaceuticalsmedical devicesdistributionor FDA-regulated industriesBachelor's degree in science or engineeringAuthorized to work in the US

Nice-to-Have Skills

MBAQuality Certifications (e.g.Six SigmaASQ)Experience leading climate control programs

Required Skills

Quality ManagementClimate controlTemperature mappingRegulatory alignmentFDAFood and Drug AdministrationISOEMABOPAuditsInspectionsdata-driven decision makingdigital transformationleadershipcoaching

Hard Skills

Quality ManagementClimate controlTemperature mappingRegulatory alignmentFDAFood and Drug AdministrationISOEMABOPAuditsInspectionsMatrixed organizationData-driven decision makingDigital transformationLeadershipCoaching

Soft Skills

Strong interpersonal skillsVerbal and written communicationOrganizational skillsWorkload planningCollaboration

Certifications

Preferred

MBAQuality Certifications (Six SigmaASQ)

Industry & Role

Industry Healthcare & Medical

Job Function Lead enterprise quality engineering initiatives and climate control across the organization

Role Subtype Quality Engineering Lead

Keywords for Your Resume

senior managerenterprise quality engineeringquality engineeringquality managementclimate controltemperature mappingregulatory alignmentFDAFood and Drug AdministrationISOEMAmatrixed organizationdata-driven decision makingdigital transformationleadershipcoachingauditsinspectionsBachelor's degree in science or engineeringpharmaceuticalshealthcare

Deal Breakers

Lack of 10+ years quality experience, No FDA/regulated industry experience, Inability to work in hybrid remote locations

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