Sr. Principal Associate for Analytical Quality Assurance - Foundry

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 110,000 - 170,000; Full time

Job summary

Lilly Medicines Foundry in Indiana seeks a Sr. Principal Associate for Analytical Quality Assurance to provide quality oversight for laboratory activities, ensure data integrity, and support the quality management system for GMP testing and analytical development.

You will lead QA reviews of deviations, OOS investigations, and method verification/validation, collaborate with Lilly quality organizations, drive continuous improvement, and promote a strong quality culture in laboratory operations

Qualifications

• Bachelor’s degree + minimum 5 years technical laboratory experience.
• Pharmaceutical QA experience preferred.
• Authorized to work in the United States full-time; no visa sponsorship.

Responsibilities

• Provide quality oversight in Analytical testing: molecule/modality support, qualification of new contract labs, audit support, quality system ownership, lead analytical compliance projects, and review quality documentation (deviations, change records).
• Provide quality oversight of method verification, qualification, and validation.
• Ensure quality systems are in place and used; facilitate quality improvement and implementation of new quality standards.
• Evaluate impact of incidents on material quality or data integrity.
• Ensure investigations for deviations, stability failures, and OOS results; review/approve related documentation.
• Perform QA review/approval/rejection of GMP documentation and ensure expert review.

Skills

Analytical method development

GMP knowledge

Quality management systems

Laboratory testing experience

Stakeholder communication

Education

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

Job description

Organization/Position Overview

Sr. Principal Associate for Analytical Quality Assurance provides quality oversight for laboratory activities in the Lilly Medicine Foundry and with external partners, ensuring cGMP compliance and data integrity; supports quality management system establishment for GMP testing/analytical development.

Responsibilities

• Provide quality oversight in Analytical testing: molecule/modality support, qualification of new contract labs, audit support, quality system ownership, lead analytical compliance projects, and review quality documentation (deviations, change records).
• Provide quality oversight of method verification, qualification, and validation.
• Ensure quality systems are in place and used; facilitate quality improvement and implementation of new quality standards.
• Evaluate impact of incidents on material quality or data integrity.
• Ensure investigations for deviations, stability failures, and OOS results; review/approve related documentation.
• Perform QA review/approval/rejection of GMP documentation and ensure expert review.
• Consult on quality-related issues; network with Lilly quality organizations and share best practices.
• Promote quality culture and oversee quality presence in laboratory areas.
• Identify and lead process improvement projects impacting multiple business areas.

Basic Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field + minimum 5 years technical laboratory experience; pharmaceutical QA experience preferred.
• Experience in fast-paced environments; large-scale capital project delivery experience highly desirable.
• Strong knowledge of analytical method development/validation.
• Strong knowledge of GMP expectations and quality management systems.
• Minimum 5 years laboratory/analytical testing experience.
• Authorized to work in the United States full-time; no visa sponsorship.

Additional Preferences

• Ability to manage dynamic environments; influence complex technical decisions; implement innovative processes with quality/acceleration.
• Networking experience; coaching/mentorship; relationship building and influence.
• Strong communication; prioritize issues and implement solutions.
• High learning agility; drive KPIs/metrics/data analysis.

Other Information

• Initial location: Parkwood West, Carmel, Indiana.
• Permanent location: new Lilly Medicines Foundry, Lebanon, Indiana.