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.
As the Associate Director of QA for the Formulation and Filling departments within the Cartridges Module, you will be responsible for ensuring full compliance with GMP standards and corporate quality requirements. You will also oversee all operational activities related to environmental monitoring in sterile injectable production areas. In this leadership role, you will guide your team toward achieving business goals while maintaining the highest standards of quality and safety. You will report directly to the Quality Executive Director and manage a team of approximately 30 people, including 2 direct reports (managers) and 2 professionals.
Key Responsibilities
- Provide Quality Oversight across all operations within the Cartridge Module, ensuring strict adherence to GMPs and Global Quality Standards (GQS) in formulation, filling, and visual inspection.
- Lead and manage environmental monitoring activities in Grade A (end-of-batch, end-of-campaign) and Grade B areas, ensuring compliance and data integrity.
- Actively participate in cross-functional teams
- Inspire and align your team with the company’s mission, vision, and strategic objectives, fostering a culture of accountability and continuous improvement.
- Manage a diverse and skilled team, promoting technical and interpersonal development through coaching, feedback, and training.
- Drive productivity improvements through targeted projects within your area of responsibility.
- Review and approve deviations, change controls, qualification protocols, job descriptions, and training curricula for your team.
- Ensure manufacturing operations are aligned with European GMPs and the regulatory requirements of all target markets.
- Support internal self-inspection programs and represent the site during regulatory inspections.
- Ensure adequate resources are available to support batch release activities for semi-finished products manufactured at the Sesto site.
- Contribute to the production of clinical trial materials.
Qualifications
- Master’s degree in a scientific discipline (e.g., Chemistry, Pharmaceutical Chemistry and Technology, Pharmacy, Biology)
- Fluent in both English and Italian
- Minimum 7 years of experience in Quality Assurance and/or Quality Control within the pharmaceutical industry
- At least 2 years of leadership experience in a Quality function
- Knowledge of sterile processes
This position requires working on-site, and includes 4 days of remote work per month.
What we offer:
- 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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