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Manager, Product Quality
Eli Lilly and Company. Serve as Product Quality Lead for assigned program(s) .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmaceutical quality assurance, including risk assessment, regulatory compliance, and quality trend analysis. Proficient in GMP manufacturing practices and adept at collaborating with cross-functional teams to support product quality and compliance.
Highest-signal resume keywords
Pharmaceutical Quality ExperienceGMP Manufacturing KnowledgeRisk Assessment DevelopmentRegulatory Submissions SupportProduct Quality Trend Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality SystemsDeviation ReviewCAPA ManagementChange Control ReviewProduct Complaint InvestigationTemperature Excursion EvaluationRisk MonitoringManufacturing Documentation ArchivalData AnalysisReporting Activities
Soft Skills
Adaptive Problem SolverCuriosityGrowth MindsetDrive for Innovation
Industry Keywords
Life SciencesClinical OperationsTechnical OperationsSupply ChainRegulatory AffairsAuditsInspectionsManufacturing Campaigns
About the role
Key responsibilities & impact- Serve as Product Quality Lead for assigned program(s)
- Investigate and finalize reporting activities for potential product complaints
- Support Clinical Operations in evaluating product temperature excursions
- Support manufacturing campaigns and release activities
- Ensure archival for expedient retrieval of key manufacturing documentation
- Review deviations, investigations, CAPAs, and change controls for adequacy
- Analyze and report on product quality trends
- Facilitate development of risk assessments and mitigation activities
- Perform routine risk monitoring activities
- Partner with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing teams to support regulatory submissions
- Support inspections and audits
Requirements
What you’ll need- BS/MS in Life Sciences
- 5-10 years pharmaceutical quality experience
- Qualified applicants must be authorized to work in the United States on a full-time basis
- Lilly will not provide support for or sponsor work authorization or visas for this role
- Knowledge of GMP manufacturing and quality systems
- Adaptive problem solver
- Technical depth and a growth mindset
- Curiosity and drive for self-identified innovation, especially in artificial intelligence and digital
Benefits
Comp & perks- Company bonus depending in part on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical benefits
- Dental benefits
- Vision benefits
- Prescription drug benefits
- Healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities