Eli Lilly and Company · 5 hours ago
Sr. Director - Quality Assurance
US, Indianapolis IN
Full-time
Onsite
Director/Executive
$156K/yr - $253K/yr
15+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. The Senior Director, IRLT Site Quality Leader is responsible for Quality Assurance and Quality Control for the manufacture of radioligand therapeutics, leading quality initiatives and ensuring compliance with regulatory guidelines while fostering a culture of quality at the site.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Ensure the design, compliance, and success of the site’s QMS in alignment with applicable regulatory guidelines and Lilly quality standards as appropriate for varying product lifecycles and unique characteristics of radiopharmaceuticals
Lead efforts to define radiopharmaceutical controls and expectations within the Lilly quality system
Define and implement an adequate QA/QC organization, roles and responsibilities, and quality oversight
Proactively evaluate and routinely inspect for potential failure modes within the QMS, define improvements, and assure robust controls for areas of risk. Lead, identify, escalate, and implement compliant risk-based solutions for quality related issues to Executive and corporate Quality Leadership
Ensure controls are established to implement, oversee and assure site performance, inspection readiness, and report performance to management
Strategically identify and implement quality improvement plans aligned with corporate objectives for QA/QC and manufacturing success
Host regulatory inspections and lead inspection support teams
Collaborate with global teams to establish resources and solutions to drive effectiveness, efficiency, productivity, and assure radiopharmaceutical integration with the corporate quality system
Foster strong collaborative relationships with stakeholders, including the site leadership team, business partners, vendors, and service providers
Coach and mentor quality staff to continuously strengthen technical and leadership capabilities
Serve as a member of the Site Leadership Team (SLT) and influence site strategy
Qualification
Required
Bachelor's degree (BS/BA) in Science, Chemistry, or Life Science
15+ years of cross-functional Quality experience supporting GMP manufacturing (Pharmaceutical, Biotech, or Medical Device industry)
10+ years of direct team management experience in Quality
Expert knowledge of cGMP requirements from early phase to commercially approved pharmaceutical products, analytical laboratory and quality control, quality audits, root cause investigations, and unique radiopharmaceutical controls
Demonstrated success leading multi-functional QA and QC teams and staff career development
Highly experienced with inspection readiness, FDA and foreign regulatory authority inspections, quality remediation activities and regulatory inspections
Experienced with the design and continuous improvement of quality management systems
Preferred
Skilled at problem solving, decision making, financial and resource management, and strategic planning in a dynamic environment
Proven ability to coach, mentor, and teach
Ability to manage globally impacting complex projects and shifting priorities
Strong stakeholder engagement and relationship-building skills
Proficiency in Microsoft Office (Outlook, Word, PowerPoint, Excel)
Benefits
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)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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2026-01-25
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