Senior Associate, PR&D Quality Systems

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.

Overview/Position Summary: 

The Product Research & Development (PR&D) Quality Systems Team is responsible for the overall strategic leadership and management of PR&D Quality System (QS) documents, including the business processes supporting the PR&D QS documents.  The Manager, PR&D Quality Systems will be responsible for overseeing the review, approval, and maintenance of Quality System documents, partnering with key business areas, and maintaining the integrity of the PR&D QS. 

Responsibilities: 

• Manage PR&D QS documents through applicable preparation, review, approval, and maintenance processes to meet business and compliance needs. 

• Project management of multiple deliverables/documents to ensure accurate and timely implementation, often within aggressive deadlines. 

• Support Document Owners, Reviewers, and Approvers and communicate key process expectations. 

• Build, maintain, and leverage relationships with customers and business partners to achieve results. 

• Own, manage, and lead key PR&D QS Team processes to ensure ongoing compliance and audit readiness. 

Basic Requirements: 

• Bachelor’s degree, preferably in a scientific or business-related field.  

• Demonstrated performance in document processing and technical writing. 

• In-depth knowledge of GXPs. 

• Advanced computer skills (especially in electronic document management systems and Microsoft Office).  

• Strong project management, communication, organizational, and problem-solving skills. 

• Ability to maintain high levels of accuracy while managing multiple tasks. 

• Must have a keen eye for detail and the ability to spot errors quickly. 

Additional Preferences: 

• Previous experience working in a forward-facing, “customer support focused” environment with capability to build cross functional relationships.  

• Proven ability to work well within a Team and demonstrate strong collaboration to meet shared goals. 

• Capable of working autonomously to meet shared goals and critical timelines. 

Additional Information: 

Physical Demands/Travel: 

The physical demands of this job are consistent with an office environment.    

The physical demands