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.
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.
This role involves developing procedures, training materials, qualifying lead investigators, facilitating deviation review meetings, monitoring program performance, and representing the site program during regulatory inspections.
Additionally, the Program Owner will 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 (e.g., strategies, procedures, and policies).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, including observation deviations and moderate deviations.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, including working with cross-functional teams.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.Experience with facility or area start-up activities.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.
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