"Alerted.org

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.

The GXP Risk Assessor/Audit Planner is part of the Global Quality Auditing and Compliance (GQAAC) division and provides quality assurance through the conduct, documentation and appropriate dissemination of risk assessments and the development of a risk-based audit plan in support of the execution of internal and external quality audits related to pharmaceutical development, non-clinical and clinical research, and product commercialization.

The role is pivotal to achieving the Lilly objective of guaranteeing compliance with regulations, internal and industry standards in all geographies where the company operates and of further enhancing the quality of operations of Lilly and their contracted parties, through the development and execution of a risk-based audit program. Through a deep technical knowledge of the regulatory framework across Pharmacovigilance, Regulatory, Medical, and Product Quality functions, and the design and execution of robust risk assessment processes, the GXP Risk Assessor/Audit Planner assures that a documented annual audit plan is generated based on risk and impact of the activities and processes related to the Lilly auditable units universe.

GQAAC is operating as a valued business partner and taking a proactive approach to further enhance the quality status of business operations and to ensure regulatory compliance. The GXP Risk Assessor/Audit Planner plays a key part in the implementation of this strategic approach to quality auditing oversight.

Basic Requirements:

+ 5+ years of experience in the pharmaceutical quality space

+ BS degree or higher in business, life sciences or related-field

Key Objectives/Deliverables:

The following activities and responsibilities will be fulfilled according to current quality standards, quality manuals, policies, procedures, and tools. These responsibilities are not intended to be all-inclusive.

Leverage technical experience, and internal and external knowledge to drive decisions required to fulfil regulatory requirements for GXP audit planning, with broad network/functional impact:

+ Lead and conduct risk assessments of Pharmacovigilance, Regulatory, Medical, and Product Quality functions for the generation of the GQAAC risk-based annual audit plan. Auditable units include, but are not limited to: Lilly affiliates; Lilly processes; Lilly central functions; third party organizations/external parties supporting or involved in Lilly processes, activities and workflows; and business alliances that have an impact on the fulfilment of Lilly’s responsibilities as a clinical trial sponsor, medicine manufacturer and/or marketing authorization holder.

+ Maintain the annual audit plans through a change control mechanism.

+ Maintain, through well designed and robustly executed data gathering processes, a deep and broad understanding of company’s organization, processes and systems related to GXP activities, including: the quality systems; the pharmacovigilance system master file (PSMF); the collection, management and submission of suspected adverse reactions; periodic safety reporting; post-authorization safety studies (PASS); signal detection; development, maintenance and dissemination of safety information; risk management activities and risk minimization measures; good pharmacovigilance practices; pharmacovigilance inspections and audits; regulatory processes supporting clinical research, registration and commercialization; medical processes (GCP and non-GCP regulated); and pharmaceutical product quality processes (excluding development and production).

+ Maintain, through well designed and robustly executed data gathering processes, a deep and broad understanding of the role and responsibilities of Lilly affiliates, third party organizations, and business alliances in the execution of the above-described activities and in the fulfilment of Lilly regulatory obligations and expectations related to GXP activities.

+ Understand internal GXP business areas and functions, including the role of the Qualified Person for Pharmacovigilance (QPPV), Lilly’s external party engagements and acquisition strategies, and any changes in these, to inform audit planning risk assessments and to adjust these as appropriate.

+ Define, maintain and update the audit universe in scope for audit planning risk assessments to ensure it reflects regulatory requirements.

+ Define, maintain and update risk classifications and risk assessment tools as agreed with GQAAC management and in alignment with the current pharmacovigilance system master file (PSMF), where appropriate.

+ Understand the content and structure of the Pharmacovigilance System Master File (PSMF) as a source for audit planning risk assessments.

+ Maintain the audit strategy to ensure compliance with any applicable regulatory requirements (e.g.: EU GVP, specifically module IV).

+ Develop and implement data and information gathering methods to ensure awareness of changes that may significantly impact pharmacovigilance and other regulatory risks, and to ensure that those changes in risk are translated into audit plan changes, when appropriate.

+ Represent GQAAC both within the company and externally; review, provide input, and influence external policies and trends affecting GQAAC risk assessments and audit planning.

+ Monitor regulations and guidelines to ensure audit planning risk assessments comply with external requirements.

+ Establish and uphold business processes and system requirements to ensure they align with regulatory standards, documenting them within the quality management system when necessary. Create new processes and system capabilities to comply with external regulations, internal business needs, and operational demands.

+ Review GXP metrics for areas of risk and propose appropriate mitigation strategies through audit planning.

+ Enable successful implementation of GQAAC Management/Lead team technical strategies and improvements.

+ Serve as an ad hoc participant of GQAAC lead team meetings to provide technical guidance and consultation, as needed.

+ Integrate information obtained through risk assessments and audit planning and influence actions within and across GQAAC and the business areas involved and impacted.

+ Drive the escalation of any compliance issues or significant risks identified during risk assessments and audit planning.

+ Work collaboratively with peers to ensure risk assessment and audit planning are done with a comprehensive perspective across GXP.

+ Establish and maintain collaborative relationships with internal partners involved in and affected by the risk assessment and audit planning process and its outputs.

Global Quality – Business Related Responsibilities:

+ Own, participate in or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed. Identify the need and drive the revision of GQAAC quality system documents when appropriate.

+ Participate in or lead the preparation of organizational metrics and trending of audit findings, when required.

+ Provide audit-related advice to GXP operations on the interpretation of corporate and regulatory GXP requirements related to quality management, when required.

+ Establish and maintain relationships with relevant business areas and regulatory authorities, including support for 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.

Personnel Development:

+ Actively participate in external activities related to the job.

+ Provide GXP technical mentorship and training to individuals within and external to the organization. Support training and qualification of peers. Act as a proactive coach for others within the organization under the highest standards of quality.

+ Maintain excellent 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 Learning Plan.

+ 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 projects and departmental teams.

This role is located onsite in Indianapolis, IN and is not approved for remote work. Flexibility allows for 4 days per month to be worked from home.

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 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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$121,500 - $198,000

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.

\#WeAreLilly