Sr. Director - API Manufacturing Quality Assurance

Reposted Yesterday
Be an Early Applicant
Huntsville, AL, USA
In-Office
156K-229K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Sr. Director of Quality Assurance oversees the Site Quality Leader for an API manufacturing facility, ensuring compliance with cGMP standards and managing the API Quality Team.
Summary Generated by Built In

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

$156,000 - $228,800

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

Skills Required

  • Bachelor's degree
  • 10+ years of pharmaceutical manufacturing quality experience
  • 5+ years of supervision/leadership experience

Eli Lilly and Company Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Eli Lilly and Company and has not been reviewed or approved by Eli Lilly and Company.

  • Strong & Reliable Incentives Pay is considered competitive with annual increases, bonuses, and equity programs that link rewards to contributions and business performance. Incentive structures and stock opportunities strengthen total compensation.
  • Retirement Support Retirement programs combine a matched savings plan, a pension, and company equity options. Financial advising and retiree health coverage reinforce long-term security.
  • Parental & Family Support Parental leave is generous for all parents, with additional paid time for birth mothers and financial support for adoption or surrogacy. Backup care services, childcare options, and caregiver concierge support further aid families.

Eli Lilly and Company Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Indianapolis, IN
39,451 Employees
Year Founded: 1876

What We Do

Eli Lilly and Company engages in the discovery, development, manufacture, and sale of products in pharmaceutical products business segment. For more than a century, we have stayed true to a core set of values – excellence, integrity, and respect for people – that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.

Similar Jobs

Tapestry - Coach and Kate Spade Logo Tapestry - Coach and Kate Spade

Temporary Associate

eCommerce • Fashion • Other • Retail • Sales • Wearables • Design
Hybrid
Foley, AL, USA
16000 Employees
15-19 Hourly

Cox Enterprises Logo Cox Enterprises

Search Engine Optimization Specialist

Artificial Intelligence • Automotive • Greentech • Information Technology • Machine Learning • Software • Cybersecurity
Remote or Hybrid
United States
50000 Employees
22-33 Hourly

Magna International Logo Magna International

IT Industry 4.0 Lead Developer

Automotive • Hardware • Robotics • Software • Transportation • Manufacturing
Hybrid
Birmingham, AL, USA
171000 Employees

Pluralsight Logo Pluralsight

Product Manager

Edtech • Information Technology • Software
Remote or Hybrid
USA
1000 Employees
106K-139K Annually

Similar Companies Hiring

Camber Thumbnail
Fintech • Healthtech • Social Impact
New York, New York
90 Employees
Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Mobile • Insurance • Healthtech • Financial Services • Artificial Intelligence
New York, New York
23 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account