Eli Lilly and Company · 2 weeks ago
Senior Director, Quality Assurance - Site Quality Leader
Pleasant Prairie, WI
Full-time
Onsite
Director/Executive
$152K/yr - $222K/yr
10+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and bringing life-changing medicines to those in need. The Senior Director, Quality Assurance, serves as the Site Quality Leader, responsible for ensuring an effective Quality Management System and compliance with regulatory requirements in a state-of-the-art manufacturing facility.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Ensure that an effective Quality Management System is in place
Ensure compliance with cGMPs, policies, procedures and standards that are required to support parenteral manufacturing, device assembly, and packaging
Effectively influence the leadership on strategic direction and tactical implementation of the quality system
Establish the site´s quality objectives, priorities, and roadmap
Lead and/or participate in the assessment, development, and implementation of critical projects in support of continuous quality improvements
Provide quality support for achieving key business objectives
Provide leadership and direction in managing product-related quality matters, assuring the independence of the quality unit, while making decisions regarding quality issues
Ensure that the products are fit for their intended use and comply with global regulatory requirements
Lead and respond to regulatory agency inspections and inquiries
Stay true to Lilly’s values of Integrity, Excellence and Respect for People
Ensure a safe and healthy work environment
Get strong participation from the Quality team to HSE program
Monitor, verify, evaluate, and drive improvement towards site goals
Ensure staff is qualified, that the initial & continuous training/ GMP education of all personnel is carried out as needed
Develop people capability & knowledge (technical expertise, behavioral & managerial)
Ensure communication of the quality objectives and priorities to all site personnel
Manage resources according to quality objectives, site priorities & anticipate future business needs including headcount and finances
Actively recruit, coach, and develop personnel within the Lilly Quality unit
Ensure that Quality activities are performed in accordance with procedural requirements and meet planned timelines
Provide administrative support & technical leadership to the site Quality unit
Assures the independence of the Site Quality Unit
Ensures the development, adequacy, and effectiveness of the site’s quality management system
Ensures systems are in place to release or reject raw materials, intermediates, packaging materials, device components, and consumables
Establish and ensure a system is in place for evaluating and releasing batch records in accordance with regulations and company standards
Ensure all necessary controls, testing, and monitoring are carried out with the quality control function in accordance with the marketing authorization
Ensure a system is in place for approving specifications, sampling instructions, test methods & batch records
Ensure that all required quality agreements are in place & maintained
Ensure site processes, equipment, instruments, utilities & facilities are qualified/validated and maintained for the intended use
Ensure that there is a process at the site to perform root cause investigation for quality matters (deviations, complaints, stability failures, results out specification) and there is a system for monitoring of corrective actions
Ensure there is a process for evaluating proposed changes
Ensure the site has a CAPA program and a quality plan where corrections and corrective actions and significant quality improvement/enhancement initiatives are described
Ensure development, approval and implementation of Local Quality Plan and Site Quality Manual
Ensure that a process of governance and control is in place (Quality Lead Team, established Deviation Review Board, Change Control Board, CAPA board) to ensure monitoring of quality indicators applied to each element of the quality system, discuss the results and actions to improve Quality Management systems and execution (Management Review of Quality Systems)
Ensure that the notification/escalation process is effective, so there is appropriate resolution of quality problems
Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS
Cooperate with Qualify Person and the Global Quality leader in communication to Health Authorities (if applicable) ensuring timely reporting
Participate in approving Annual Product Reviews
Ensure site audit & inspection readiness
Host audits and inspections
Assure timely closure of all regulatory commitments
Assure the adequacy & effectiveness of the site quality systems
Participate in the Site Lead Team and lead the Quality Lead Team
Ensure overall compliance with GMP regulations, Lilly Corporate Quality standards and regulatory requirements through review and approval of GMP documentation
Ensure the site has a process to maintain compliance status through gap assessment of corporate and regulatory standards and guidelines
Ensure adequate quality oversight on GMP documents and activities (e.g., through QA presence on the shop floor)
Qualification
Required
Bachelor of Science degree or equivalent in a scientific field (e.g., pharmacy, chemistry, microbiology, engineering)
Minimum of 10 years' experience in the pharmaceutical industry in parenteral operations
Minimum of 10 years' leadership experience (Ideally in Quality Assurance)
Demonstrated history of hosting regulatory inspections
Preferred
Demonstrated Technical writing ability
Demonstrated strong oral and written communication
Demonstrated ability in problem solving and critical decision-making
Demonstrated ability to coach, mentor and lead others
Demonstrated interpersonal skills with ability to influence cross-functionally and externally
Demonstrated self-motivated leadership, ensuring a fair and equitable work environment
Clear understanding of cGMPs, policies, procedures, and guidelines
Demonstrated ability to maintain a safe work environment
Benefits
Company bonus (depending, in part, on company and individual performance)
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)
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
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reference. (Data Powered by US Department of Labor)
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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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2026-01-14
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2026-01-14
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