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.

Organization Overview:

The PR&D Quality Systems (QS) Team is responsible for the overall strategic leadership and management of the PR&D Quality System (QS), including the business processes that support PR&D QS documents. As part of this team, the Manager is responsible for overseeing the review, approval, and maintenance of QS documents, partnering with key business areas, and ensuring the integrity of the PR&D QS.

Responsibilities:

PR&D QS Management

• Manage PR&D QS documents through preparation, review, approval, and maintenance processes to meet business and compliance needs.
• Oversee the periodic review process to ensure compliance requirements and timelines are met.
• Maintain the integrity of the Quality System Index.
• Apply knowledge of current business, regulatory, industry, and overarching requirements to uphold the quality of all documents and the integrity of the PR&D QS.
• Ensure accurate and timely implementation of deliverables/documents.

Customer Interaction & Influence

• Support stakeholders and teams with expertise in PR&D QS and document management processes.
• Guide Document Owners, Reviewers, and Approvers by communicating key process expectations.
• Collaborate with Learning & Development to drive action and ensure process requirements and deadlines are met.
• Build, maintain, and leverage relationships with customers and business partners to achieve results.
• Anticipate customer needs and provide proactive support.

Process Leadership and Improvement

• Own, manage, and lead key Standards Team processes to ensure ongoing compliance and audit readiness.
• Identify and implement improvements to business processes supporting the PR&D QS.
• Participate in and contribute to project initiatives.
• Leverage technical expertise to influence key process decisions.

Basic Requirements:

• Bachelor of Science in applicable field
• ​2+ years of experience working with quality
• Experience with Document Management Systems and processes (Veeva Vault)

Additional Skills/Preferences:

• In-depth knowledge of GXPs.
• Familiarity with Operational Excellence principles.
• Understanding of Risk Management principles.
• Technical writing experience.
• Strong project management, communication, and problem-solving skills.
• Advanced computer skills (Microsoft Office).
• Demonstrated collaboration to meet shared goals.

Additional Information:

• On Site Expectations: minimum of 3 days on site

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

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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