Expert Specialist - M&Q

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ppAt Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. /ph3Job Summary /h3pWe are seeking an Expert Specialist in Manufacturing Quality (MQ) to play a critical role in ensuring the highest standards of production and quality assurance within Eli Lilly Italia S.p.A. This role involves applying advanced expertise to complex MQ challenges, driving continuous improvement, and safeguarding product integrity. /ph3Job Responsibilities /h3ulliLead the investigation and resolution of complex quality events, deviations, and non-conformances within manufacturing operations, ensuring timely and effective corrective and preventive actions (CAPAs). /liliDevelop, implement, and maintain robust quality management systems (QMS) and procedures in compliance with national and international regulations (e.g., GMP, GLP, ICH) and company standards. /liliProvide expert guidance and technical support to manufacturing teams on MQ-related topics, including process validation, equipment qualification, and change control. /liliConduct root cause analysis for recurring MQ issues and propose innovative solutions to enhance efficiency, reduce waste, and improve overall product quality. /liliParticipate in and lead internal and external audits (e.g., regulatory inspections, supplier audits) to assess compliance and identify areas for improvement. /liliDevelop and deliver training programs on MQ principles, procedures, and best practices to various levels of the organization.



/liliCollaborate cross-functionally with RD, Supply Chain, Regulatory Affairs, and other departments to ensure seamless product lifecycle management from development to commercialization. /liliMonitor key performance indicators (KPIs) related to MQ, analyze trends, and generate reports for management review. /liliDrive continuous improvement initiatives through the application of Lean, Six Sigma, and other operational excellence methodologies. /liliStay abreast of industry best practices, emerging technologies, and evolving regulatory landscapes in the pharmaceutical manufacturing and quality control domains. /li /ulh3Job Qualifications /h3ulliBachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or a related scientific/engineering discipline. A Master's degree or Ph.D. is highly desirable. /liliMinimum of 8 years of progressive experience in Quality Assurance, Quality Control, or Manufacturing Operations within the pharmaceutical or biotechnology industry, with a significant focus on GMP environments. /liliProven expertise in pharmaceutical quality systems, including deviation management, CAPA, change control, validation, and risk management. /liliIn-depth knowledge of European and international regulatory requirements (e.g., EMA, FDA, ICH guidelines). /liliDemonstrated ability to lead complex investigations and problem-solving initiatives using structured methodologies. /liliStrong analytical skills with the ability to interpret complex data and make data-driven decisions. /liliExcellent communication, interpersonal, and presentation skills,



with the ability to influence and collaborate effectively at all levels of the organization. /liliProficiency in Italian and English, both written and spoken. /liliExperience with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies is a strong asset. /liliAbility to work independently and as part of a team in a fast-paced, dynamic environment. /liliStrong commitment to quality, compliance, and patient safety. /li /ulpLilly 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 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. /ppLillydoes 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. /ppActual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is€33,670 - €49,390 /ppFull-time equivalent employees may also be eligible for a company premio (depending, in part, on company and individual performance). /pullieligibility to participate in a pension plan /lilivacation benefits /lilieligibility for healthcare benefits /liliflexible benefits (if applicable) /lililife insurance and death benefits /lilicertain time off and leave of absence benefits /liliwell-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities) /li /ulpLilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gs4xg