Sr. Director, Quality Assurance – Materials Management & Logistics US, Indianapolis 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.

Associate Director/Director, Quality Assurance – Materials Management & Logistics
 

Position Summary:

The Associate Director, Quality Assurance, will lead the start-up and routine operation of the QA organization overseeing Materials Management and Logistics operations for the Global API Network Expansion manufacturing sites. This role will play a key part in developing and standardizing quality processes for material supplier governance, warehouse operations, and logistics activities, ensuring compliance with global quality and regulatory standards. The position requires strong leadership, collaboration across multiple functions, and expertise in materials management quality systems to support operational efficiency and regulatory readiness across new API sites.

Key Responsibilities:

1. Quality System Development & Standardization

• Define and implement a comprehensive materials management quality system aligned with global QMS and regulatory expectations.
• Establish site material supplier programs in collaboration with other Lilly manufacturing sites and global materials management teams.
• Develop and maintain an approved supplier list, Quality Agreements, material and supplier risk assessments, and periodic supplier performance reviews.
• Oversee quality assurance for warehouse operations and logistics, ensuring compliance with GMP standards.

2. Process Integration for New API Sites

• Lead the qualification and implementation of materials management quality processes to ensure seamless start-up of new manufacturing sites.
• Work cross-functionally to integrate quality requirements into project timelines and ensure regulatory and operational readiness.
• Support the development and approval of operational procedures and controls related to materials management.

3. Cross-Functional Collaboration & Supplier Governance

• Collaborate with site leadership, QA and QC teams, and global materials management teams to ensure alignment of supplier and logistics processes with global quality standards.
• Participate in material and supplier complaint handling, driving resolution and continuous improvement.
• Ensure alignment with global supplier quality programs, partnering with external vendors and internal stakeholders to optimize supplier governance.

4. Leadership & Quality Culture

• Support recruiting and capability-building efforts to establish a diverse and high-performing quality assurance team.
• Foster a strong quality culture by maintaining open communication, promoting teamwork, and driving continuous improvement initiatives.
• Provide coaching, mentorship, and performance management to direct reports, ensuring an equitable and engaging work environment.

Basic Requirements:

• Bachelor’s degree in a scientific, engineering, or pharmaceutical-related discipline (or equivalent experience).
• 3+ years of experience in pharmaceutical quality leadership, with a focus on materials QA and supplier management.
• Strong knowledge of GMP regulations, Quality Management Systems, and regulatory requirements related to materials and supplier governance.

Preferred Qualifications:

• Experience with materials management and supplier governance in a global or multi-site pharmaceutical environment.
• Familiarity with material management IT systems such as SAP, Veeva QDocs, and TrackWise.
• Previous experience in facility start-ups, equipment qualification, and process validation.
• Demonstrated ability to lead regulatory inspection readiness and execution.
• Strong problem-solving, decision-making, and technical writing skills.
• Excellent interpersonal and communication skills with the ability to influence at all levels.

Other Information:

• The role may require global travel to support site implementation and supplier oversight.
• This role is located in Indianapolis, IN and not eligible for remote work

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.

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