Senior Principal QA Lead, Analytical (Foundry)

Biopharma Careers; Lebanon (KY); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance in Lebanon, Indiana.

You will provide quality oversight for analytical testing across the Lilly Medicine Foundry, ensuring compliance with cGMP and quality standards and guiding QA activities with external partners. Responsibilities include method qualification/verification, deviations handling, and leading quality systems enhancements.

Qualifications

• Bachelor’s degree… in Pharmacy, Chemistry, Biology, or related field (required).
• Minimum 5 years of technical laboratory experience with QA in pharma.
• Strong knowledge of analytical method development/validation and GMP expectations.
• Experience with quality management systems and documentation reviews (deviations, changes).

Responsibilities

• Provide quality oversight in analytical testing, including qualification of labs, audits, and quality documentation.
• Oversee method verification, qualification, and validation activities.
• Ensure quality systems are used and drive quality improvement initiatives.
• Evaluate potential impact of incidents on material quality or data integrity.
• Lead investigations for deviations, stability failures, and OOS results and approve related documentation.
• Perform QA review/approval of GMP documentation and ensure proper expert sign-off.
• Be a point of contact on quality issues and network with Lilly quality organizations.
• Promote a strong quality culture and monitor quality presence in labs.
• Identify and lead cross-functional process improvement projects.

Skills

Quality assurance experience

Analytical testing oversight

GMP knowledge

Deviation/investigation handling

Quality systems understanding

Process improvement

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field

Tools

LIMS

Job description

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance in Lebanon, Indiana.

You will provide quality oversight for analytical testing across the Lilly Medicine Foundry, ensuring compliance with cGMP and quality standards and guiding QA activities with external partners. Responsibilities include method qualification/verification, deviations handling, and leading quality systems enhancements.