Senior Analytical QA Lead (GMP & Method Validation)

Regulatory Jobs; Lebanon (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Pension

Vacation benefits

Job summary

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance in Indiana. The role ensures lab activities at the Lilly Medicine Foundry adhere to global and site quality standards and cGMP, maintaining data integrity and regulatory compliance.

The position supports design and construction phases, providing quality oversight for GMP testing, analytical development, and qualification of methods and instrumentation, while establishing and maintaining a robust quality management system.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field.
• Minimum 5 years of technical laboratory experience in QA.
• Strong knowledge of analytical method development and validation.
• Familiarity with current GMP expectations and quality management systems.
• Experience with large-scale capital project deliveries is desirable.
• Authorized to work in the United States full-time.

Responsibilities

• Provide quality oversight for analytical testing, including qualification of labs and quality documentation.
• Oversee method verification, qualification, and validation activities.
• Lead quality improvement initiatives and implement new quality standards.
• Investigate deviations, stability failures, and out-of-spec results.
• Review and approve GMP documentation with technical experts.
• Collaborate with Lilly quality organizations to implement quality systems.
• Promote a positive quality culture across laboratory areas.
• Identify and lead cross-functional process improvement projects.

Skills

Quality Assurance

cGMP knowledge

Analytical testing

Audit support

Quality systems

Documentation review

Communication skills

Leadership

Process improvement

Problem solving

Education

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

Tools

Analytical instruments

Laboratory QA systems

Job description

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance in Indiana. The role ensures lab activities at the Lilly Medicine Foundry adhere to global and site quality standards and cGMP, maintaining data integrity and regulatory compliance.

The position supports design and construction phases, providing quality oversight for GMP testing, analytical development, and qualification of methods and instrumentation, while establishing and maintaining a robust quality management system.