Senior Director, Global Process Owner – Quality Risk Management
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: Indianapolis • North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $151,500 - $222,200 per year
Job Level
Senior
About the role
- Establish and maintain the global quality system for QRM to drive standardization globally
- Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations
- Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset
- Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement
- Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics
- Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance
- Monitor performance metrics, report and provide insights to inform decision making to drive further improvements
- Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools
- Actively collaborate with enterprise-wide teams on standardized global business processes
- Ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed
- Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Quality Risk Management
- Own the global risk log and global risk register, ensuring that key quality risks across the enterprise are actively being mitigated
- Support the Quality Maturity Model initiatives by actively enhancing the cultural mindset across the enterprise to integrate QRM principles into routine processes
Requirements
- 10+ years’ experience in the pharmaceutical industry in GxP roles, with several years Quality experience
- Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field
- Proven ability to work in a matrixed organization with diverse teams and influencing areas not under direct control
- Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities
- Proficiency in addressing operational challenges through structured approaches and innovative solutions
- Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data
- Demonstrated change agility in anticipating and leading others through change and ambiguity
- Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks
- Demonstrated people management experience
- Expertise in navigating and ensuring adherence to global regulatory standards and frameworks
- Prior experience with common QRM tools, how and when to apply them, and maintenance of a risk log or risk register
- Prior experience working in at least two of Clinical Operations/Development, Pharmacovigilance, Product Research & Development or Commercial Manufacturing preferred
Benefits
- eligibility to participate in a company-sponsored 401(k)
- pension
- vacation benefits
- eligibility for medical, dental, vision and prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance and death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Risk ManagementGxPData analysisProcess improvementGovernance structuresRisk logRisk registerRegulatory complianceQuality metricsPharmaceutical industry
Soft skills
Strategic thinkingChange agilityInfluencingCollaborationMentoringLeadershipCommunicationProblem-solvingDecision makingAdaptability