Sr. Director - API Manufacturing Quality Control

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 – QC provides strategic and administrative leadership for the quality control and analytical sciences laboratories at a new Lilly API site. This role ensures the development of essential capabilities and business processes to support site operations and Lilly’s expanding pipeline.

Responsibilities

Business Support

• Build and lead a high-performing Quality Laboratory Operations team
• Ensure GMP compliance across all lab activities
• Deliver the “lab of the future” vision with integrated digital, paperless processes
• Collaborate with local and global quality teams to standardize lab design, processes, and systems
• Participate in site and quality leadership teams
• Drive strategic decisions and successful business outcomes
• Coordinate lab-related planning and budget management
• Promote cross-functional integration and communication
• Maintain a safe, compliant work environment
• Serve as a liaison for corporate communications

Compliance Oversight

• Ensure consistent quality and compliance across laboratories
• Manage regulatory and internal inspections

Personnel Development

• Lead HR planning, performance management, and talent development
• Recruit and build site capabilities for a high-functioning QC lab organization
• Ensure strong administrative and technical leadership within the team

Basic Qualifications

• Bachelor’s degree in relevant field (STEM preferred)
• 10+ years of supporting complex analytical testing (mass spec, bioassay, protein characterization)
• 5+ years of supervisory/leadership experience

Additional Preferences

• Knowledge of QC operations, new product introduction, and process development
• Expertise in analytical lab quality and compliance requirements
• Experience with regulatory submissions
• Proficient in Microsoft Office and other computer systems
• Strong technical writing and communication skills
• Effective interpersonal skills with ability to lead leaders and influence cross-functionally
• Commitment to maintaining a safe work environment

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.

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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

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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