Eli Lilly and Company · 9 hours ago
Sr. Manager - QA Assurance
Durham, NC
Full-time
Onsite
Mid, Senior Level
$94K/yr - $139K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking a Senior Manager, Quality Assurance to provide leadership and technical oversight in their manufacturing facility, ensuring compliance with regulatory requirements and driving continuous improvement in quality processes.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence
Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement
Establish and monitor performance objectives, providing feedback and coaching to drive team development
Identify business and quality risks, escalating appropriately and in a timely manner
Provide continuous quality improvement oversight to regulated processes, practices, and documentation
Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements
Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues
Work cross-functionally with process teams for metrics reviews, operational support, and deviation management
Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance
Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings
Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines
Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes
Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions
Qualification
Required
Bachelor's or Master's degree in Engineering, Life Sciences, or related field
5+ years of experience in Quality Assurance, with at least 3 years in a leadership role
Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements
Demonstrated attention to detail and ability to maintain quality systems
Previous experience leading or working effectively with a cross-functional group
Demonstrated excellent interpersonal, written and oral communication skills
Demonstrated strong technical aptitude and ability to train and mentor others
Demonstrated decision making and problem-solving skills
Demonstrated ability to organize and prioritize multiple tasks
Preferred
Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc
Previous experience with Manufacturing Execution Systems and electronic batch release
CQM, CQE, or CQA certification from the American Society for Quality (ASQ)
Previous experience with Trackwise, Veeva, MODA
Benefits
Company bonus (depending, in part, on company and individual performance)
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)
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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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