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 work worldwide to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We prioritize our work and put people first. We seek individuals determined to improve lives globally.
Drug Product External Manufacturing Quality Assurance
This department ensures the safety and efficacy of drug products worldwide by overseeing contract manufacturers and alliance partners throughout all process steps, from selection to termination.
We focus on creating open communication partnerships and maintaining effective relationships with alliance partners, contract manufacturers, and internal customers.
Position: DPEM Compliance Specialist
The specialist will oversee DPEM and Contract Manufacturers’ quality systems, including:
* Ensuring inspection readiness, developing an inspection calendar, representing DPEM at PAI readiness meetings, and sharing observations and trends within DPEM and with Lilly sites.
* Monitoring quality systems through quality plans and self-inspection programs.
* Leading Deviation and Change Control boards (CRB/DRB).
* Analyzing deviations and change control trends for DPEM and CMs.
* Maintaining site-to-site quality agreements between DPEM and Lilly sites/functions.
* Managing the DPEM quality metrics process and driving continuous improvement.
* Participating actively in QLT and other relevant forums.
Qualifications
Education:
* Bachelor's Degree in Pharmacy, Chemistry, or equivalent experience.
Experience:
* GMP compliance experience.
* Experience in technical and quality roles within manufacturing is highly valued.
Skills:
* Understanding of GMPs and Lilly Global Quality Standards.
* Strong communication and attention to detail.
* Analytical skills and a mindset for continuous improvement.
* Interpersonal skills and the ability to work effectively in cross-functional teams.
* Organizational, prioritization, multitasking, and influencing skills.
* Decision-making and problem-solving abilities.
* Ability to operate in virtual and complex environments.
* Appreciation for cultural diversity.
Additional Information
Lilly is committed to providing accommodations for individuals with disabilities during the application process. If needed, please complete the workplace accommodation request form. Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, veteran status, disability, or other protected statuses.
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