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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 PR&D Quality System Associate Director provides critical leadership, oversight, and cross functional influence and integration to ensure that the processes and systems supporting the PR&D Quality System (QS) are well managed. The PR&D Quality System Associate Director partners cross functionally with the business to implement key quality projects, uphold quality standards and compliance to applicable regulations, and drive continuous improvement efforts within PR&D. The PR&D Quality System Associate Director is responsible for the overall leadership and management of the PR&D Quality System (QS), including the business processes supporting PR&D QS documents.

Leadership and People Development

• Supervise a team that manages the PR&D QS documents through applicable preparation, review, approval, and maintenance processes necessary to meet business and compliance needs for PR&D.
• Elevate the team’s performance by setting clear goals and objectives and providing real time feedback, coaching/mentoring, career development, and succession management to staff.
• Ensure that staff is highly trained in the activities they execute in support of the PR&D QS including knowledge of the applicable cGXP expectations and requirements.
• Ensure the right organizational structure is in place for accomplishing goals, developing talent, and staffing to meet future needs by understanding and anticipating required future skills.

PR&D Quality System Support

• Ensure the continuing integrity of the PR&D QS through effective management and execution of the document management processes and systems.
• Work with PR&D QA Leadership to continually re-evaluate the strategy and state of compliance of for PR&D QS. Proactively provide solutions to drive continuous improvement.
• Identify and measure quality metrics that are relevant and drive improvement.
• Lead/participate on teams and projects focused on efforts to improve systems and processes.
• Participate as a member of the PR&D Quality Lead Team(s) to ensure engagement with customer groups.
• Ensure PR&D QS is compliant with global quality standards and procedures and external regulations.
• Actively network internally and externally to expand knowledge of applicable technology, regulations, and best practices that ultimately drive continuous quality improvements throughout PR&D and drive a quality mindset.
• Support internal audits and external regulatory inspections.

• Bachelor’s degree in a scientific or medical related field or equivalent work experience.
• 7+ years of QMS experience within the pharmaceutical industry.

• Experience in Quality, the business and supervision.
• Strong working knowledge of cGMP requirements and GCP regulations.
• Strong leadership and teamwork skills.
• Able to work and accomplish results through people.
• Solid judgement and initiative.
• Strong influence skills.
• Strong and effective written and verbal communication skills in cross functional settings and across different levels of the organization.
• Demonstrated change agent.

This role requires the individual to be onsite in Indianapolis, IN at least three days per week.