Eli Lilly and Company · 1 month ago
Sr Manager, Quality Assurance - Parenteral (Night Shift)
US, Pleasant Prairie WI
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, focused on discovering and bringing life-changing medicines to those in need. The Night Shift Sr. Manager, Quality Assurance will oversee the QA organization for Parenteral operations, providing technical and administrative leadership while managing a team and ensuring compliance with quality requirements.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
The Night Shift Sr. Manager, Quality Assurance, will support the start-up and routine operation of the QA organization overseeing Parenteral operations at Lilly's Kenosha, Wisconsin pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership, as well as project management
Serve as technical resource to review and approve technical documents
Network with cross-functional technical project delivery team to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework
Work with the Associate Director, Quality Assurance to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on the formulation, filling and visual inspection programs
Support initial recruiting, build capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production
Manage a team of up to approximately 15 direct reports
Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc
Network with global and other parenteral sites to understand best practices and share knowledge
Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management
Support inspection readiness activities
Interact with regulatory agencies during inspections regarding cGMP issues
Ensure data integrity by design
Qualification
Required
Bachelor's degree in a science, engineering, pharmaceutical-related field of study or equivalent experience
5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group
Preferred
Commit to successfully maintain Lilly Computer System Quality Assurance (CSQA) Certification
Strong knowledge of Quality Management Systems and applicable regulatory requirements
Previous experience directly supporting a pharmaceutical manufacturing operation
Excellent interpersonal, written and oral communication skills
Strong technical aptitude and ability to train and mentor others
Demonstrated technical writing skills
Demonstrated problem-solving and decision-making skills
Previous facility or area start up experience
Previous equipment qualification and process validation experience
Previous experience with highly automated syringe filling, vial filling, and visual inspection equipment
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 deviation and change management systems including Trackwise
Benefits
Company bonus
401(k)
Pension
Vacation benefits
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
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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
2026-01-12
2026-01-12
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