Principal Associate - QA (Clinical External Manufacturing)

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.

Main Purpose and Objectives of Position:

The Quality Assurance Principal Associate has the responsibility for providing cGMP compliance oversight and batch release for Product Research and Development (PR&D) Clinical Trial activities manufactured at Collaboration Partners (CPs). The Quality Assurance Representative provides assistance within CP parenteral and dry products CT Operations including auditing, cGMP documentation review and approval, deviation (event) investigations, change control, procedures, specifications, quality agreements, and any other quality related activities.

Scope:

Large and Small Molecule products, clinical trial manufacturing and associated collaboration partners, Product Research and Development.

Key Responsibilities:

Support Parenteral and Dry Products External Manufacturing within PR&D, particularly as it relates to decisions associated with impact to the quality of products.

Perform pre- and post- review of batch production records utilized for manufacturing.

Approve/Release DP batches for Clinical Trial Materials (Batch Disposition).

Author and review change controls and deviation/event investigations. Assess the impact of change controls and events on the product and regulatory commitments.

Maintain and provide support on the interpretation of the quality system and cGMP compliance.

Maintain and analyze site quality metrics.

Support and / or evaluate the disposition of batches, including management and review of GMP documentation, analytical results and regulatory commitments.

Responsible for communication with affiliate sites and Collaboration Partners (both US and OUS) to obtain approval documentation and regulatory requirements.

Ensure inspection readiness through compliance auditing, site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems.

Provide support for internal and regulatory site inspections.

Identify opportunities for and participate in continuous improvement projects.

Approve or reject GMP documents such as specification, components, containers closures, in-process materials to be used in Clinical Trials. This involves review and approval of production and control records, maintaining batch records and issuing/approving applicable certificates (i.e. Certificates of Analysis) and extending retest dating.

Responsible of the Quality Assurance oversight of CT parenteral and dry products external manufacturing. Responsible for maintaining CMO qualification status activities including: evaluation of contract manufacturers; participation in due diligence, drafting, review and approval of quality agreements and associated documents.

Work with business partners to ensure that data supplied to regulatory agencies to support product decisions are accurate and complete. This may include approving stability protocols, reviewing stability data, ensuring that the assays used meet regulatory requirements and verifying data in and approving the final report. This responsibility also includes establishing expiration dates for CT material.

Perform other related duties, as assigned.

Minimum Requirements:

Bachelor’s degree in applicable Life Sciences (Pharmacy, Chemistry, Engineering, etc).

5+ years of relevant quality assurance manufacturing experience.

Additional Preferences:

Demonstrated ability to work independently or as part of a team to resolve issues.

Previous experience in QA, QC, Ops, TS/MS, Engineering, or Regulatory is desirable.

Demonstrated strong technical writing and communication skills.

Root Cause Analysis/Troubleshooting skills.

Additional Information:

Potential domestic and international travel less than 10% per year. Occasional travel may be required for collaboration partner oversight, training, conferences, etc.

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 ( 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$96,000 - $162,800

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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