Director, External Quality Control – Stability

Eli Lilly and Company

. Develop and lead analytical quality control strategy across multiple programs .

Posted 10/23/2026full-timeRemote • United StatesLead💰 $117,000 - $259,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in analytical quality control strategy development and execution, ensuring regulatory compliance and effective supplier management. Proficient in analytical method validation, stability program oversight, and providing tactical support for regulatory submissions.

Highest-signal resume keywords

Analytical Quality Control Strategy DevelopmentRegulatory Compliance ManagementAnalytical Method ValidationSupplier Qualification and RemediationQuality Control Program Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical ChemistryQuality ControlAnalytical Method TransferStability Program DesignTesting Results ReviewRegulatory Submissions SupportHealth Authority InspectionsIssue ResolutionQuality Documentation ReviewStrategic Vision Development

Industry Keywords

Pharmaceutical SciencesCMC FilingsRegulatory ComplianceSupplier RelationshipsQuality Attributes Monitoring

About the role

Key responsibilities & impact

Develop and lead analytical quality control strategy across multiple programs
Review analytical methods, specifications, and validation activities and collaborate on updates
Support analytical method transfer
Collaborate on supplier qualification and/or remediation activities
Oversee stability program design and execution across multiple programs
Monitor and report on stability trends and product quality attributes
Ensure ongoing regulatory compliance of stability activities
Manage ongoing supplier relationships
Perform routine reviews of testing results and quality documentation
Drive issue resolution to facilitate regulatory compliance
Provide tactical support for regulatory submissions
Support health authority inspections and audits
Review analytical and stability sections within CMC filings

Requirements

What you’ll need

BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field
10+ years quality control and analytical development experience
Experience developing strategic vision and providing tactical support for quality control programs

Benefits

Comp & perks

Company bonus depending in part on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities