Principal / Sr. Principal Associate - Pharmacovigilance Quality Auditor

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.

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

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 35,000 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.

The 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 Global Quality Auditor assures that GxP operations conducted or sponsored by Lilly are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations, applicable guidelines and industry standards.

GQAAC is operating as a valued business partner and taking a proactive approach to further enhancing the quality status of business operations and regulatory compliance.  The Quality Auditor plays a key part in contributing to the implementation of this strategic approach to quality auditing oversight.

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

• Scheduling, preparing, conducting and reporting GQAAC audits and assessments of GxP operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines.
• Participate in or lead the risk assessment of GxP operations in support of generating the GQAAC risk-based annual audit plan.
• Appropriately escalate any compliance issues.
• Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.

This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.

Global Quality – Business Related Responsibilities:

• Identify the need and drive the revision of GQAAC quality system documents when appropriate. Participate in or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed.
• Participate in or lead the preparation of organizational metrics and trending of audit findings, when required.
• Provide advice to research and manufacturing operations on the interpretation of corporate and regulatory GxP requirements, when required.
• Establish and maintain relationships with relevant regulatory authorities, including supporting or facilitation of regulatory inspections, when required.
• Provide technical expertise in identifying, formulating, assembling and delivering quality and compliance education to customers, as required.
• Influence internal and external customers and partners when improvement needs are identified.

Personal Development

• Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
• Complete required training for the roles identified in the Individual Training Plan (ITP)
• Be continually aware of current industry trends and regulatory agency interpretation of GxP requirements.
• Seek 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.
• Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams.
• Support training and qualification of other auditors.

Minimum Requirements:

• 5+ years of experience within Global Patient Safety/Pharmacovigilance either at Lilly or within the pharmaceutical environment.
• Bachelor’s Degree in a science or health care related field, Health care professional, i.e., Pharmacist, Nurse, biological sciences, or other technical area.

Additional Preferences:

• Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
• Proven ability to think and analyze from a process perspective. Project management skills.
• Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.
• Work independently as well as collaboratively within a global team environment.
• Deliver constructive feedback to customers while providing a high level of customer service.
• The ability to understand detailed scientific information, while remaining anchored in the “Big Picture”.
• Ability to interpret and apply regulations, regulatory guidance, codes and public expectations and identify and recommend compliance changes as appropriate.
• Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
• Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
• Experience working on a global team and sharing knowledge.
• Experience with computers and entering data into databases.
• Good analytical/problem-solving skills.
• Experience working with Third Party Organizations.

Other Information:

Domestic 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.

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.

Lilly is an EEO/Affirmative Action Employer and does 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-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.

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