Quality Assurance Associate - Drug Product 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.

Company Overview

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 35,000 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.

Position Overview

Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, Central and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation / validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

The QA Lead for Contractor Manufacturers (CMs) provides daily oversight, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure / master formula revisions, validations and other duties associated with daily CM activities.  This role provides and assures compliance to Lilly GQS by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing and / or packaging product. The QA Lead is integral for maintaining GMP compliance and providing support during preparations for Pre-Approval / General inspections by various agencies.  The QA Lead is integral for launching new products, packages, processes, and CM's.

The Principal Associate QA may also be responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured / packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.

Key Objectives / Deliverables :

• Lead / provide support to launch new products / packages / CMs
• Participate on Joint Process Teams
• Understand Lily global quality systems and monitor the CM process to ensure it is compliant as applicable and ensure complaint to Regulatory expectations.
• Levelling, reviewing, and approving of event investigations and changes.
• Work with Lilly support groups and SME’s to resolve product related issues
• Participate in the creation and revision of standard operating procedures
• Participate on Six Sigma Projects to help improve productivity
• Provide support on site or remotely during inspections
• Author and track compliance to the CM Quality Agreements and CM Quality Plans
• Ensure CMs are following Quality Agreement and appropriate quality systems as part of routine operations. Use regular visits, JPTs and other communications to help to assess / monitor performance.
• Routinely have face-to-face communications with CMs
• Track and monitor Quality metrics for trends at the CM
• Support Qualifications / Validation document creation and reviews
• Provide and coordinate designated sections for Annual Reports and Annual Product Reviews
• Execute SOP assessments of CMs and track completion of outstanding issues
• Support CMs effort to maintain and improve their quality systems
• Provide technical leadership and project management oversight to drive improvements to CM quality systems
• Build and maintain regular communication with External Manufacturers and awareness of issues / progress including reporting back to DPEM Management. Also responds to request of information and data.
• Benchmark with other Lilly sites to share best practices and drive improvements to CM oversight
• Network with external partners and resources to share and learn best practices and trends within the industry
• Support batch release activities by determining final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations.

Basic Qualifications :

Additional Skills / Preferences :

Additional Information :

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

$63,000 - $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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