Expert Specialist - M&Q

At Lilly, the work is demanding because patients are waiting.

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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.

Job Summary

We are seeking an Expert Specialist in Manufacturing & Quality (M&Q) to play a critical role in ensuring the highest standards of production and quality assurance within Eli Lilly Italia S. p.

This role involves applying advanced expertise to complex M&Q challenges, driving continuous improvement, and safeguarding product integrity.

• Job Responsibilities
• Lead the investigation and resolution of complex quality events, deviations, and non-conformances within manufacturing operations, ensuring timely and effective corrective and preventive actions (CAPAs).
• Develop, 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.
• Provide expert guidance and technical support to manufacturing teams on M&Q-related topics, including process validation, equipment qualification, and change control.
• Conduct root cause analysis for recurring M&Q issues and propose innovative solutions to enhance efficiency, reduce waste, and improve overall product quality.
• Participate in and lead internal and external audits (e. g., regulatory inspections, supplier audits) to assess compliance and identify areas for improvement.
• Develop and deliver training programs on M&Q principles, procedures, and best practices to various levels of the organization.
• Collaborate cross-functionally with R&D, Supply Chain, Regulatory Affairs, and other departments to ensure seamless product lifecycle management from development to commercialization.
• Monitor key performance indicators (KPIs) related to M&Q, analyze trends, and generate reports for management review.
• Drive continuous improvement initiatives through the application of Lean, Six Sigma, and other operational excellence methodologies.
• Stay abreast of industry best practices, emerging technologies, and evolving regulatory landscapes in the pharmaceutical manufacturing and quality control domains.
• Job Qualifications
• Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or a related scientific/engineering discipline. A Master's degree or Ph. D. is highly desirable.
• Minimum 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.
• Proven expertise in pharmaceutical quality systems, including deviation management, CAPA, change control, validation, and risk management.
• In-depth knowledge of European and international regulatory requirements (e. g., EMA, FDA, ICH guidelines).
• Demonstrated ability to lead complex investigations and problem-solving initiatives using structured methodologies.
• Strong analytical skills with the ability to interpret complex data and make data-driven decisions.
• Excellent communication, interpersonal, and presentation skills, with the ability to influence and collaborate effectively at all levels of the organization.
• Proficiency in Italian and English, both written and spoken.
• Experience with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies is a strong asset.
• Ability to work independently and as part of a team in a fast-paced, dynamic environment.
• Strong commitment to quality, compliance, and patient safety.

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.

Lillydoes 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is€33,670 - €49,390

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance).

• eligibility to participate in a pension plan
• vacation benefits
• eligibility for healthcare benefits
• flexible benefits (if applicable)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e. g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly 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.

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