PpAt 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. /p h3Position Brand Description /h3 pThe Sr. Principal Associate – Quality Auditor is part of the Global Quality Auditing and Compliance (GQAAC) division and provides quality assurance through the execution of internal and external audits in support of pharmaceutical development, non‑clinical and clinical research, product commercialization, pharmacovigilance and consumer information quality (CIQ) for Lilly. Through auditing, the Sr. Principal Associate – Quality Auditor assures that GXP operations conducted and sponsored by Lilly are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations and applicable guidelines and industry standards. /p pGQAAC has adopted a proactive approach to ensure the effective implementation of a continuous quality assurance program. This program has the objectives of guaranteeing compliance with regulations in all geographies where Lilly operates and of further enhancing the quality of operations of Lilly and their contracted parties. The Sr. Principal Associate – Quality Auditor is an expert quality professional, acting as a key contributor to the development and execution of the GQAAC audit program within the GXP area(s) of responsibility. /p h3Key Objectives / Deliverables /h3 pThe following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive: /p h3Auditing /h3 ul liScheduling, preparing, conducting and reporting Global Quality audits and assessments of research and commercial operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines. This includes leadership of audit teams –including GXP- and ability to successfully execute a portfolio of complex audits as lead or solo auditor, as appropriate (e.g.: for cause, process and system audits, affiliates, large TPOs and pre‑inspection audits). Performance of this work requires limited supervision. /li liParticipate in mock‑inspections, as appropriate. /li liParticipate or lead the risk assessment of research and commercial operations. Integrate the information obtained through auditing and risk assessment and influence actions within and across GQAAC and the business areas involved/impacted. /li liDrive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment. /li liMeet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools. /li /ul h3Global Quality – Business Related Responsibilities /h3 ul liIdentify the need and drive the revision of GQAAC quality system documents when appropriate. Participate or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed. /li liParticipate or lead the preparation of organizational metrics and trending of audit findings, when required. /li liProvide advice to research and manufacturing operations on the interpretation of corporate and regulatory GXP requirements, when required. /li liEstablish and maintain relationships with relevant regulatory authorities, including supporting or facilitation of regulatory inspections, when required. /li liProvide technical expertise in identifying, formulating, assembling and delivering quality and compliance education to customers, as required. /li liInfluence internal and external customers and partners when improvement needs are identified. /li /ul h3Continuous Improvement Related to Role /h3 ul liParticipate in the continuous improvement agenda related to the role to ensure compliance within a continually changing company, regulatory and industry landscape. /li liRepresent assigned process within broader change and transformation initiatives. /li liPartner with GPhV risk assessor to drive innovation, simplify and standardize audit processes, including implementation of risk‑based paper‑based audit programs, where appropriate. /li liEnable successful implementation of GQAAC Management/Lead team technical strategies and improvements. /li /ul h3Personal Development /h3 ul liMaintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills. /li liComplete required training identified in the Individual Learning Plan. /li liBe continually aware of current industry trends and regulatory agency interpretation of GXP requirements. /li liSeek self‑development in GXP areas (e.g. grand rounds, attend training courses, conferences or association meetings) and share such information and knowledge with other members of the group or company to increase internal intelligence. /li liMentor others in the implementation of GXP requirements. /li liParticipate or lead divisional improvement efforts, including Six Sigma projects and departmental teams. /li liAct as a proactive coach for others within the organization: focused on systematic execution under highest standards of quality. The Sr. Principal Associate – Quality Auditor is considered a person of reference within the function / team for technical and general auditing advice. /li /ul h3Minimum Requirements /h3 ul liBachelors Degree – Preferred degree in physical or biological sciences, or other technical area. /li liMinimum of five (5) years’ experience related to Pharmacovigilance (PV) or pharmaceutical industry. /li /ul h3Additional Preferences /h3 ul liExperienced in working with Third Party Organizations. /li liAbility to analyze detailed technical scientific information, while understanding the bigger picture. The senior auditor should be able to clearly identify and assess risk and impact associated with specific and overall findings and situation for an auditable unit, event or case, and to articulate such risk and impact when communicating to the business (including senior management) and the quality organizations. /li liAbility to interpret and apply regulations, regulatory guidance, codes and public expectations, and identify and recommend compliance changes as appropriate. /li liExcellent interpersonal skills, ability to remain constructive and civil in difficult situations. /li liAbility to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization. /li liExperienced in working on a global team and sharing knowledge. /li liExperience with computers, entering and managing data in databases. /li liGood analytical/problem‑solving skills. /li liAbility to handle several complex projects in parallel. /li liSystematic approach to ensure self‑safety and that of the audit team. /li liWork under pressure on multiple tasks concurrently and meet deadlines in a fast‑paced work environment with frequent interruptions and changing priorities. /li liProven ability to think and analyze from a process perspective. Project management skills. /li liProcess information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments. /li liWork independently as well as collaboratively within a global team environment. /li liDeliver constructive feedback to customers while providing a high level of customer service. /li liAbility to influence and manage change/conflict. /li liAbility to think on your feet and be pragmatic in decision making. /li /ul h3Other Information /h3 pDomestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 40% (duration 1‑2 weeks), sometimes on short notice. /p pLilly 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. /p pLilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. /p pActual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 – $187,000. /p pFull‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day‑care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and 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. /p p#WeAreLilly /p h3Seniority Level /h3 pMid‑Senior level /p h3Employment Type /h3 pFull‑time /p h3Job Function /h3 pQuality Assurance /p h3Industries /h3 pPharmaceutical Manufacturing /p pGet notified about new senior quality auditor jobs in bSesto Fiorentino, Tuscany, Italy /b. /p /p #J-18808-Ljbffr