Sr. Director - API Manufacturing Quality Assurance

Regulatory Jobs; Huntsville (AL); On-site; USD 156,000 - 229,000; Full time

Job summary

Lilly is currently constructing an advanced manufacturing facility for production of API molecules. The Sr. Director – QA will serve 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. The Sr. Director – QA leads the API Quality Team, drives QA strategy, coordinates regulatory inspections, and maintains

Qualifications

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

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.

Skills

Site QA leadership

cGMP compliance

Regulatory compliance

Quality systems

Leadership

Statistical analysis

Education

Bachelor's degree in STEM

Tools

Quality Management System (QMS)

Document control systems

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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 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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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.

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