Associate Director - TSMS Sterility Assurance

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.

This role will be responsible for ensuring that all sterile product manufactured in our site comply to regulatory requirement and internal quality standard by managing a team of microbiologists and technicians who perform batch release testing on all sterile products.  The role reports directly to Director of Quality Control.  
Responsibilities

• Lead the execution of all sterility assurance activities including but not limited to:
• Handle the day to day operations of the Batch Release Unit
• Ensure adherence to cGMPs during batch release testing
• Coordinate batch release testing schedules based on production timelines
• Respond to customer/client requests or events as they occur
• Interact regularly with external customers (e.g., sales, marketing, agencies) and internal customers (all levels of management, engineering, maintenance, production, QC, Regulatory Affairs, Technical Service, etc.) to ensure business needs are met and to provide updates on new projects or initiatives
• Support investigations related to quality complaints involving sterility of products produced at the site
• Provide input into the development of new methods, processes, and products
• Applies innovative & logical risk-based thinking and decision making
• Plans strategically while performing subtly
• Maintains a positive attitude and energy level despite facing obstacles
• Demonstrates flexibility in work assignments and responsibilities
• Establishes relationships with key stakeholders

Qualifications:

• Master’s degree in Microbiology or equivalent required;
• Experience leading a team of scientist required
• Minimum of 10 years relevant experience in GxP regulated industry with increasing responsibility in Sterility Assurance required
• Proven knowledge of cGMPs and FDA regulations required
• Strong project management skills required
• Ability to communicate effectively and influence others
• Proficient English language skill both written and verbal required

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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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