Eli Lilly and Company · 1 day ago
Sr. Director - QC Labs IPM
Indianapolis, IN
Full-time
Onsite
Director/Executive
$152K/yr - $222K/yr
10+ years expEli Lilly and Company is a global healthcare leader dedicated to improving lives through innovative medicines. The Senior Director - QC Labs IPM is responsible for overseeing product testing and ensuring compliance with quality systems, while leading the quality control team and managing regulatory inspections.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals
Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports; participate on the plant lead team and Parenteral Quality Lead Team
Serve as a conduit for corporate communications; exhibit critical business decision making bringing about successful results
Create and manage Site Quality Plan; recruit new talent, technical and compliance consistency across plants; coordinate and manage regulatory inspections
Communicate to and strive for integration of support groups outside of the plant
Recruit / retain effective diverse staff, supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment
Leadership role in the implementation of quality systems
Influence development of improved and streamlined quality systems
Provide technical support and expertise for site and Corporate on analytical topics
Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility issues
Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure customer needs are met
Network with other sites regarding new systems development and best practices for analytical processes
Develop plan for capital purchases
To approve or reject, as they see fit, starting materials, packaging materials, intermediate, bulk, and finished products
To ensure that all necessary testing is carried out and the associated records evaluated
To approve specifications, sampling instructions, test methods, and other Quality Control procedures
To approve and monitor any contract analysts
To ensure the qualification and maintenance of their department, premises, and equipment
To ensure that the appropriate validations are done
To ensure that the required initial and continuing training of their department personnel is carried out and adapted according to need
To ensure adequate design, effective implementation, monitoring, and maintenance of the quality management system. These may include, subject to any national regulations
The authorization of written procedures and other documents, including amendments
The monitoring and control of the manufacturing environment
Plant hygiene
Process validation
Training
The approval and monitoring of suppliers of materials
The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities
The designation and monitoring of storage conditions for materials and products
The retention of records
The monitoring of compliance with the requirements of Good Manufacturing Practice
The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality
Participation in management reviews of process performance, product quality, and of the quality management system and advocating continual improvement
Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
Qualification
Required
Bachelors of Science degree in Chemistry, Microbiology, or related science field
10+ years of experience in pharmaceutical industry with previous supervisory experience
Preferred
Experience in Production, Quality Control, Quality Assurance, Technical Services, Regulatory, or Administration is desirable
Previous analytical and/or micro experience
Experience interacting with regulatory agencies
In-depth understanding of chemistry and/or microbiology principles relating to pharmaceutical products
Deep understanding of compliance requirements and regulatory expectations relating to material and product testing
High-quality skills to include ability to prioritize, written and oral communication, critical decision making, interpersonal / people, computer applications, problem solving, mentoring / leadership
Self-motivation, lead the way for ensuring a fair and equitable work environment; clear understanding of all cGMPs, policies, procedures, and guidelines
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
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
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
2026-01-07
2026-01-07
Company data provided by crunchbase