Sr. Principal Associate - Global Quality Auditing and Compliance

Location: Sesto Fiorentino

Sr. Principal Associate - Global Quality Auditing and Compliance
Eli Lilly and Company
• Sesto Fiorentino, Firenze, IT
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.
Key Objectives/Deliverables
The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all‑inclusive:
Auditing Responsibilities

Interpret and apply Lilly standards, regulations, regulatory guidance, industry standards, to identify compliance risks and maintain a comprehensive knowledge of applicable regulations, technical knowledge, and training to meet the auditing responsibilities.
Lead or participate in planning, scheduling, preparing, conducting, appropriately escalating compliance issues, and reporting audits, assessments, and due diligences of GMP operations to assess the level of compliance with established standards and current regulations and guidelines.
Lead or participate in risk assessments and mock regulatory inspections of GMP operations to assess level of compliance and/or readiness to meet established standards and current regulations and guidelines, as applicable.
Provide technical input and recommendations to audit observation reports during the Audit Review Board meeting, as applicable.
Exhibit ethical behavior when auditing, including integrity, objectivity, and confidentiality, including the competency to recluse oneself from an audit when a conflict of interest or lack of competency in a specific area exists.
Exhibit interpersonal skills that are relevant to auditing, such as listening, questioning, being tactful and having appropriate non‑verbal skills, handling conflict in a constructive manner and communicating (both written and verbal) in a clear and concise manner.

Business‑related Responsibilities

Lead or participate in the continuous improvement of the GQAAC quality system and other GQAAC organizational priorities.
Participate in the continuous improvement of the global quality system and other corporate priorities, as requested.
Establish and maintain relationships with the relevant business units, including providing audit‑related advice, interpretation of Lilly global quality standards and regulations, and inspection readiness assistance.
Participate and/or support GQAAC self‑assessments or regulatory inspections.

Personnel Development Responsibilities

Complete required training and qualifications as identified in your Learning Plan.
Remain current of regulatory and industry trends, including regulatory agency interpretation of requirements.
Serve as a mentor and coach for others within the GQAAC organization.
Attend training courses, conferences, or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness, as assigned.

Minimum Requirements

Minimum of five (5) years’ experience related to the pharmaceutical industry.

Additional Preferences

Ability to work safely to ensure self‑safety and the safety of others.
Strong working knowledge of global regulations and guidelines (e.g., FDA, EU, and industry standards such as ICH, ISPE, PIC/s) for GMP operations and the ability to interpret and apply regulatory and guidelines to the pharmaceutical industry.
Prior auditing experience, including auditor certification by an external body (e.g., ASQ Quality Auditing).
Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while working under short deadlines associated with a fast‑paced dynamic scientific environment.
Ability to deliver timely and professional communications (oral and written) with…