Sr. Principal Associate for Analytical Quality Assurance - Foundry

Scorpion Therapeutics; Lebanon (IN); On-site; USD 125,000 - 175,000; Full time

Job summary

Lilly Medicines Foundry in Carmel, IN is seeking a Sr. Principal Associate for Analytical Quality Assurance to provide quality oversight across GMP testing and analytical development with internal and external partners.

The role ensures the quality management system is followed, supports method development/validation, and leads QA initiatives that improve data integrity and regulatory compliance across multiple projects.

Qualifications

• Bachelor's degree and 5+ years of QA laboratory experience in pharma.
• Strong knowledge of GMP and quality management systems.
• Experience with analytical method development and validation.

Responsibilities

• Provide quality oversight in analytical testing and audits.
• Oversee method verification, qualification, and validation.
• Ensure quality systems are implemented and continuously improved.
• Evaluate incident impact on material quality and data integrity.
• Review GMP documentation and ensure technical review.
• Collaborate with Lilly quality organizations to share best practices.
• Promote a positive quality culture in lab areas.
• Lead process improvement projects across multiple business areas.

Skills

Quality Assurance

Analytical Method Validation

Documentation Review

Education

Bachelor's degree in related field

Job description

Organization and Position Overview:

Sr. Principal Associate for Analytical Quality Assurance provides quality oversight for laboratory activities at the Lilly Medicine Foundry and with external partners to ensure compliance with global/site quality standards and cGMP. Oversees establishment and adherence to the quality management system for GMP testing and analytical development; supports qualification of analytical methods and instrumentation.

Responsibilities:

• Provide quality oversight in analytical testing (molecule/modality support, qualification of contract labs, audit support, quality system ownership, lead analytical compliance projects, assess quality documentation such as deviations and change records).
• Oversee method verification, qualification, and validation activities.
• Ensure appropriate quality systems are in place; facilitate quality improvement and implementation of new quality standards.
• Evaluate incident impact on material quality or data integrity.
• Ensure investigations for deviations, stability failures, and OOS results; review and approve related documentation.
• Review/approve/reject GMP documentation and ensure technical expert review/approval.
• Consult on quality-related issues as needed; network with Lilly quality organizations and share best practices.
• Promote a positive 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 + 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 and validation.
• Strong knowledge of current GMP expectations and quality management system execution.
• Minimum 5 years experience in laboratories/analytical testing.
• Must be authorized to work in the U.S. Full-time; Lilly does not sponsor visas.

Additional Preferences:

• Adaptable to change; influences complex technical decisions.
• Experience driving innovative, quality-focused process improvements; networking across industry.
• Mentorship/coaching; relationship building; strong communication.
• High learning agility; able to design KPIs/metrics and analyze data.

Other Information:

Initial location: Parkwood West, Carmel, Indiana; permanent location: Lilly Medicines Foundry, Lebanon, Indiana.