Sr. Manager - TSMS Validation

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.

Are you ready to make a difference? We are seeking a Sr Manager – TSMS Validation to join our Technical Services and Manufacturing Science (TSMS) organization. In this pivotal role, you will report directly to the Director – TSMS Sterility Assurance and Validation and lead a team of 10 talented professionals and technicians.

This is more than a job—it’s an opportunity to contribute to the production of life-saving medicines that improve and transform patients’ lives around the world. Your expertise in validation will ensure that our processes and equipment meet the highest standards of quality and compliance, enabling us to deliver treatments that truly matter.

Role Objectives

• Oversee initial qualification activities for new equipment and manage Periodic Validation of existing equipment, including periodic review of qualification status.
• Ensure adherence to the Validation plan, coordinating internal and external resources as needed.
• Manage the department’s Capital budget, ensuring adequacy of technology and equipment through the acquisition of new tools and periodic review of existing ones.
• Maintain and oversee TSMS documentation within Quality Docs and LRM2 systems, either personally or through team members.
• Lead and coordinate all activities of a complex team, ensuring operational efficiency and compliance.

Main Responsibilities

• Guarantee execution of Periodic Validation and Cleaning Validation for equipment, minimizing impact on production activities and coordinating qualified personnel.
• Ensure preparation of documentation for periodic review of equipment qualification status.
• Manage TSMS laboratories and instruments, ensuring they are maintained in optimal condition.
• Collaborate on Capital budget management for the acquisition of inventory materials within available funds.
• Drive the identification and introduction of new technologies and innovations for validation and qualification tools.
• Act as department representative for Quality Docs and LRM2, ensuring proper maintenance and periodic verification of electronic and paper validation documentation.
• Chair the TSMS Safety Team, ensuring coverage of all TSMS activities.
• Participate in network activities related to periodic validation and preparation/use of reference tools.

Required Qualifications

• Master’s Degree in Technical/Scientific disciplines
• Fluent in both Italian and English
• Minimum of 7 years of experience in validation, equipment qualification, or related pharmaceutical/manufacturing roles
• Previous experience in people management, preferably with cross-functional groups within a matrix organization
• Proven communication and team coordination skills, troubleshooting ability, and experience in interactions with regulatory authorities.
• Managerial capabilities in team leadership, including selection, recruitment, development, and growth of professionals and technicians.

This position requires working on-site and includes 4 days of remote work per month.

What we offer:

Step into a role where your expertise is recognized, appreciated, and rewarded. As a member of our team, you can expect:

• Competitive Salary: We offer a competitive base salary supplemented by an annual variable component based on achieving objectives.
• Relocation Package: You will be eligible for a relocation package based on your location.
• Comprehensive Benefits: Enjoy a well-rounded welfare package, including an extensive insurance plan.
• Annual Salary Review: We recognize and reward your continued effort with an annual salary review, providing opportunities for advancement based on your performance. As part of our commitment to your future, you may also be eligible to receive a stock option package, aligning your success with the company's growth.

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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