Principal Associate-PRD QA CT Drug Product mfg at Eli Lilly and Company

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.

Organization Overview:
Product Research and Development (PRD) Quality Assurance (QA) supports the delivery of the Lilly pipeline by providing oversight of the manufacturing, packaging, and distribution of the medicines needed for clinical trials (CT).  As the QA Principal Associate, CT Drug Product Manufacturing, you will be responsible for the quality oversight of CT drug product manufacturing.  CT Drug Product Manufacturing is responsible for manufacturing parenteral and oral products at partner sites across the globe, both internally (e.g. B103, PR01) and externally.

Responsibilities:

The Quality Assurance Principal Associate performs Quality functions and oversight for PR&D drug product manufacturing. Assure the PR&D Quality System is in compliance with global regulations and aligned with current industry practices and the Lilly global quality standards, where appropriate.  Advise local business on current quality system expectations and develop and implement plans to address local compliance gaps.  Provide technical QA support by leading/participating in divisional projects and supporting the portfolio as needed.

• Oversight of manufacturing collaboration partners.
• Perform pre-manufacture activities such as pre-approval of master batch records.
• Perform activities related to forward processing and final usage decision of batches.
• Advise business partners on quality system and regulatory requirements/interpretations.
• Partner with internal molecule project teams and external CPs on quality related matters, issue resolution, deviation investigations, etc., to ensure successful manufactures.
• Participate in or lead projects to continuously improve processes.

Basic Requirements:

• Bachelor's or higher degree in a scientific field such as physical, chemical or biological sciences, pharmaceutics, engineering, pharmacy, computer science, or other scientific areas of study.
• A minimum of 5 years of quality unit or relevant GMP experience.
• Strong problem solving, interpersonal and leadership skills

Additional Skills/Preferences:

• Additional experience in areas such as development operations, engineering, technical services, manufacturing operations, analytical/laboratory, and/or regulatory affairs is preferred.
• Previous experience with parenteral drug product manufacturing.
• Previous experience with compounded sterile preparations.
• Previous experience with SAP, Trackwise, Quality Docs.

Additional Information:

• Potential domestic and international travel less than 20% per year. Occasional travel may be required for collaboration partner oversight, training, conferences, etc.

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