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Sr. Director, Quality Assurance (QA) – Change and Deviation Program Owner, Global API Network Expansion
Responsibilities:
The Deviation Management Program Owner is a key member of the QA & Compliance team, responsible for overseeing the site deviation management program to ensure product quality and safety.
* Develop procedures, training materials, qualify lead investigators, facilitate deviation review meetings, monitor program performance, and represent the site program during regulatory inspections.
* Collaborate with site inspection readiness teams and provide guidance to lead investigators, functional leaders, and senior quality leadership.
Key Objectives/Deliverables:
Program Development & Strategy
* Work with Network Leadership and Site Quality Leaders to shape the vision, strategy, and quality culture for deviation and change management programs.
* Serve as a technical resource for reviewing and approving program documentation.
* Collaborate with cross-functional teams to establish and continuously improve deviation and change control quality systems.
* Support recruiting efforts and build capability for a diverse leadership and quality assurance team.
Operational Readiness & Compliance
* Establish site programs by partnering with other Lilly manufacturing sites and global materials management teams.
* Develop and implement operational readiness plans for deviation and change control programs.
* Foster a strong quality culture by promoting open communication, teamwork, and employee engagement in site workflows.
* Participate in tactical and strategic business planning related to deviation and change control.
Deviation & Change Control Management
* Prepare and author deviation management and change control procedures and training materials in compliance with Lilly's Global Quality Standards and cGMP requirements.
* Develop a qualification program for deviation lead investigators and change owners.
* Establish standard processes for investigation forums, including triage meetings, impact assessments, investigation strategy sessions, root cause analysis, and CAPA alignment meetings.
* Provide technical guidance to lead investigators in deviation investigations, quality impact evaluations, root cause analysis, and technical writing.
Performance Monitoring & Approval Responsibilities
* Measure, monitor, and report Key Performance Indicators (KPIs) to Site Management.
* Review and approve deviation investigations as a technical or quality approver.
Basic Requirements:
* Bachelor's degree in science, engineering, or a pharmaceutical-related field.
* 10+ years of pharmaceutical leadership experience in deviation and change control QA.
Additional Skills/Preferences:
* Commitment to maintaining Lilly's training requirements.
* Strong knowledge of Quality Management Systems and regulatory requirements.
* Experience in deviation and change control management.
* Familiarity with Veeva QDocs, TrackWise, or similar systems.
* Excellent interpersonal, written, and verbal communication skills.
* Strong technical aptitude with the ability to train and mentor others.
* Demonstrated technical writing, problem-solving, and decision-making skills.
* Previous experience in regulatory inspection readiness and execution.
Additional Information:
* One role is based in Indianapolis, IN and may require up to 20% travel. Another role is based in Limerick, Ireland.
* These roles are not eligible for remote work.