DPEM Compliance specialist

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 worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back to our communities through philanthropy and volunteerism. We are committed to putting people first and making a meaningful impact. Drug Product External Manufacturing Quality Assurance This department ensures the safety and efficacy of drug products for patients globally by overseeing contract manufacturers and alliance partners. Responsibilities include overseeing process steps such as selection, pre-validation/validation, ongoing operations, and termination. We foster open communication and maintain effective relationships with our alliance partners, contract manufacturers, and internal teams. Role Overview: DPEM Compliance Specialist The DPEM Compliance Specialist will oversee DPEM and Contract Manufacturer (CM) quality systems, including: Ensuring inspection readiness at CMs, maintaining an inspection calendar, representing DPEM at PAI inspection readiness meetings, and sharing observations and trends. Monitoring DPEM and CMs quality systems through quality plans and self-inspection programs. Leading Deviation and Change Control boards (CRB/DRB). Analyzing deviations and change control trends. Maintaining site-to-site quality agreements between DPEM and Lilly sites/functions. Managing the DPEM quality metrics process for continuous improvement. Participating actively in the QLT and other relevant forums. Qualifications Bachelor's Degree in Pharmacy, Chemistry, or equivalent experience. GMP compliance experience. Experience in technical and quality functions within manufacturing is highly valued. Skills Technical understanding of GMPs and Lilly Global Quality Standards. Strong communication and attention to detail. Analytical thinking and a mindset for continuous improvement. Effective teamwork and interpersonal skills. Organizational, prioritization, multi-tasking, and influencing abilities. Decision-making and problem-solving skills. Ability to operate in virtual and complex environments. Appreciation for cultural diversity. Additional Information Lilly is committed to supporting individuals with disabilities to participate actively in the workforce. If you need accommodations during the application process, please complete the accommodation request form. Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or other protected categories. Summary Locations: Italy - Sesto Fiorentino; Spain - Alcobendas; US - Indianapolis IN Corporate Center; France - Fegersheim Type: Full-time J-18808-Ljbffr

Location: sesto-fiorentino, IT

Posted Date: 5/23/2025