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.

Organization Overview:
Lilly's API External Manufacturing (API EM) provides oversight for all outsourced drug substance manufacturing operations for Lilly across multiple technical platforms. API EM personnel are primarily based in Indianapolis, IN, USA and Kinsale, Ireland. API EM ensures that safe, high quality drug substance is produced at contract manufacturers to meet the needs of the patients we serve, to provide uninterrupted supply of commercial products and delivery of key portfolio programs across diverse disease states.

Responsibilities:

The API External Manufacturing (API EM) QA Associate Director ensures that API EM operations have robust quality oversight. The API EM QA Associate Director is responsible for quality projects supporting API EM, the productivity and development of the QA employees, and the quality of the API EM Tides portfolio of products manufactured by the Contract Manufacturers (CM). The API EM QA Associate Director ensures the quality systems of the CM meet Lilly quality standards and CGMPs and are compliant with Quality Agreement(s). The Associate Director will oversee the department's performance, resolution of quality issues, and compliance. This role will share the QA oversight of the Tides portfolio with an existing Associate Director due to growth of API EM oversight activities.

Key Deliverables:

Make decisions regarding the quality of batches, resolution of quality issues and quality performance for partners. This role will have responsibility for the API EM Tides plant portfolio of products, including synthetic peptides and oligonucleotides.

Lead the API EM QA team, providing coaching/feedback to develop QA employees, including performance management, talent assessments, mentoring, succession planning, and organizational planning.

Build working relationships with API EM management, key internal customers/partners, and strengthen CM alliances.

Establish and improve business processes to provide any necessary interface between the CM's and Lilly's quality systems (e.g., deviations, complaints, change management) via day-to-day interactions and maintaining Quality Agreements.

Support API EM' s efforts to maintain and improve our quality systems and ensure alignment with Lilly Global Quality Standards and regulatory agency expectations.

Coordinate quality activities for outsourcing of Lilly's targeted projects to CMs, including maintaining and improving compliant oversight practices.

Support regulatory agency inspections at the CM, provide management status updates and participate in the resolution of regulatory findings by coordinating CM and Lilly responses.

Basic Requirements:

Bachelor's in a science-related field, engineering or equivalent experience.

8+ yrs of prior experience in Manufacturing, QC, QA, Manufacturing Science & Technology, Engineering and/or Regulatory Affairs

Additional Skills/Preferences:

Hands-on experience in synthetic peptide and/or oligonucleotide manufacturing.

Proven leadership or supervisory experience, with a demonstrated ability to guide and support team members.

Proficiency in computer applications relevant to laboratory and manufacturing operations.

In-depth knowledge of Current Good Manufacturing Practices (cGMPs) and regulatory expectations.

Excellent written and verbal communication skills, with the ability to clearly convey complex scientific and technical information.

Strong attention to detail and a commitment to quality and compliance.

Familiarity with statistical tools and data analysis techniques to support process optimization and decision-making.

Outstanding interpersonal and networking skills, with the ability to collaborate effectively across teams and functions.

Strong organizational skills, with the ability to manage and prioritize multiple tasks in a fast-paced environment.

Advanced problem-solving and analytical thinking abilities, with a proactive approach to identifying and addressing challenges.

Ability to influence and engage diverse teams, fostering collaboration and alignment across global and cross-functional groups.

Additional Information:

Must complete ITP for API EM Quality Assurance Associate Director.

Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.

24 hour/day operations support may be required.

Travel is required up to 20%.

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

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