Associate Director- QA

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. Were looking for people who are determined to make life better for people around the world.

The purpose of the Associate Director - QA in IAPI (Indianapolis Active Pharmaceutical Ingredient) role is to support the development and implementation of pharmacovigilance system business goals and objectives, enabling the monitoring of the performance of the Pharmacovigilance System. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and other areas.

Pharmacovigilance System Master File (PSMF)

• Collate data required for the update of the PSMF and localized PSMFs.
• Management of PSMFs in controlled document management system and ensure assembly of the data in the format required by the regulators.
• Maintenance of required pharmacovigilance quality system summaries and delegations.
• Quality check sections of the PSMF to ensure accuracy and consistency.

Audits and Inspections

• To assist in ensuring data is available for audits and inspections.
• Provide support for audits/inspections (e.g., preparation/readiness, coordination, back room, front room, responses).
• Communicate and ensure inspection readiness for areas of responsibilities.

Other Quality Tasks

• Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents.
• Participate in quality initiatives and projects as assigned.
• Shares key learning to drive simplification and replicate best practices.
• Collaborates with other quality groups as appropriate and develops quality network.
• Establishes good working relationships with assigned business area(s).

Basic Requirements:

• Bachelors Degree in a science/technology/health care related field
• 5+ years of pharmaceutical experience

Additional Skills/Preferences:

• Experience in Quality Assurance
• IT skills in Office 365
• Effective project and time management skills
• Demonstrated ability to communicate effectively, both written and verbal, and to influence others
• Demonstrated ability to prioritize and handle multiple concurrent tasks
• Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
• Strong interpersonal skills with demonstrated flexibility in varying environments/geographies
• Experience in pharmacovigilance
• IT skills in web-based file sharing platforms and Document Management Systems
• Knowledge of quality system

This role requires the individual to be onsite 4 days per week in Indianapolis, IN and is not approved for remote work.

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 ( ) 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), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$114,000 - $167,200

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 Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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