Associate Director, Quality Assurance (QA) – Change and Deviation Program Owner, Global API Network Expansion

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.

Associate 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 or equivalent experience.
• 5+ 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.

This role is located in Indianapolis, IN and is not eligible for remote work.

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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