Sr. Director - API Manufacturing Quality Assurance

Lilly • Lebanon, IN • 9h ago

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.?

Position Overview

The Sr. Director - QA serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. This role ensures the strength and continuous improvement of all quality and compliance systems, activities, and personnel. Additionally, the Sr. Director - QA is responsible for maintaining utilities and ensuring that raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements.

Key Responsibilities

Serve as Site Quality Leader on the Lilly Site Lead Team.

Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments.

Lead the API Quality Team and manage its agenda.

Support quality forums (e.g., Deviation and Change Control Boards).

Develop and monitor a site Quality Plan and metrics.

Coordinate and manage regulatory inspections.

Review and approve manufacturing and quality system documents.

Ensure adequate QA staffing and provide coaching and development.

Use HR tools for performance management, staffing, and succession planning.

Contribute to QA business planning and site-wide strategic planning.

Basic Requirements

Bachelor's degree (STEM degree preferred)

10+ years of pharmaceutical manufacturing quality experience

5+ years of supervision/leadership experience

Additional Preferences

Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs

Proficient in statistical analysis and computer applications

Strong interpersonal, communication, and networking skills

Ability to influence diverse teams and manage multiple priorities

Demonstrated problem-solving and analytical thinking

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$151,500 - $222,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

WeAreLilly

Lilly

Go to Apply

Share this job

Similar Jobs

Forklift Operator

Ryder System • Frankfort, IN • 4h ago

Manufacturing & Warehouse

Position Description Ryder is immediately hiring a Permanent Full Time Case Picker in Frankfort, Indiana Warehouse Forklift Operator / Driver Positions Pay Weekly Hourly Pay $19.00 per hour Additional Pay: $0.75 per hour...

4h ago

Go to Apply

Warehouse Sanitation

Ryder System • Frankfort, IN • 4h ago

Manufacturing & Warehouse

Position Description Ryder is immediately hiring a Permanent Full Time Sanitation in Frankfort, Indiana Warehouse Positions Pay Weekly Hourly Pay: $19.00 per hour Apply Here with Ryder Today Click here to see and hear it...

4h ago

Go to Apply

Warehouse Associate

Ryder System • Whitestown, IN • 1d ago

Manufacturing & Warehouse

Position Description Ryder is immediately hiring Temporary Warehouse Associates in Whitestown, Indiana Warehouse Positions Pay Weekly Hourly Pay $18.24 per hour Additional Pay: $1.50 per hour when assigned to second shif...

1d ago

Go to Apply

Warehouse Associate

Ryder System • Frankfort, IN • 1d ago

Manufacturing & Warehouse

Position Description Ryder is immediately hiring a Permanent Full Time Case Picker in Frankfort, Indiana Warehouse Positions Pay Weekly Hourly Pay $19.00 per hour Overtime Pay $30.75 per hour Additional Pay: $1.50 per ho...

1d ago

Go to Apply

Warehouse Associate - Days

Performance Food Group • Plainfield, IN • 1d ago

Manufacturing & Warehouse

131638BR Job Title: Warehouse Associate - Days Location: CM Indianapolis, IN (2247) Job Description: We Deliver the Goods: Competitive pay and benefits, including Day 1 Health & Wellness Benefits, Employee Stock Purc...

1d ago

Go to Apply

Warehouse Associate

CSL Plasma • Whitestown, IN • 1d ago

Manufacturing & Warehouse

Responsibilities: Under direct supervision, assists with daily activities pertaining to shipping, receiving and storage Physically moves and maintains flow of materials and products following established procedures and s...

1d ago

Go to Apply

Warehouse Associate - Express Scripts

The Cigna Group • Whitestown, IN • 2d ago

Manufacturing & Warehouse

Location: Work on site in Whitestown, IN Sign on Bonus! Hours: Sunday-Thursday 10:00pm-6:30am Are you ready for a new job that allows you to make an impact and improve the lives of others? Express Scripts Pharmacy, a div...

2d ago

Go to Apply

Production Operator II

Newell Brands • Fishers, IN • 3d ago

Manufacturing & Warehouse

Job ID: 8704 Alternate Locations: Newell Brands is a leading consumer products company with a portfolio of iconic brands like Graco®, Coleman®, Oster®, Rubbermaid®, Sharpie® and Yankee Candle® - and 24,000 talented teamm...

3d ago

Go to Apply

Receiving Warehouse, Worker

Performance Food Group • Whitestown, IN • 5d ago

Manufacturing & Warehouse

131113BR Job Title: Receiving Warehouse, Worker Location: GRNR Indiana (2395) Job Description: Green Rabbit, recently acquired by Performance Food Group and working under their Vistar Retail Segment, is a cold storage fa...

5d ago

Go to Apply

Manufacturing Chemist I

Antech Diagnostics • Brownsburg, IN • 6d ago

Manufacturing & Warehouse

We understand that the world we want tomorrow starts with how we do business today, and that's why we're inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to...

6d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.