QA Operations Lead, GMP for Advanced Therapies

Regulatory Jobs; Lebanon (IN); Presencial; USD 66.000 - 172.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) participation

Pension

Vacation benefits

Medical, dental & vision benefits

Flexible benefits accounts

Life insurance

Well-being programs

Descripción de la vacante

Lilly is establishing a cutting-edge manufacturing site in Lebanon, Indiana, focused on Advanced Therapies including Gene Therapy. The QA Operational Support Representative will guide quality activities, from document control to inspections readiness, to ensure GMP compliance for clinical and commercial supply.

We seek a candidate with a strong QA background in pharma manufacturing, capable of mentoring teams and driving data integrity across processes, equipment validation, and change control

Formación

• Bachelor's degree in a science, engineering, computer, or pharmaceutical field or equivalent experience.
• 3+ years in pharmaceutical manufacturing Quality Assurance roles.
• Authorized to work in the United States full-time; visa sponsorship not provided.

Responsabilidades

• Lead and review GMP-compliant documents and change controls.
• Oversee equipment/facility verification from requirements through testing.
• Support inspections readiness and interactions with regulatory bodies.
• Mentor operations staff on quality culture and good documentation practices.
• Triage deviations and changes, review batch records and releases.

Conocimientos

Regulatory knowledge

Quality Assurance

Cross-functional teamwork

Documentation & data integrity

Problem solving

Educación

Bachelor's degree in science/engineering/pharma

Equivalent industry experience

Herramientas

Kneat

Veeva Vault

SAP

MES systems

Descripción del empleo

Lilly is establishing a cutting-edge manufacturing site in Lebanon, Indiana, focused on Advanced Therapies including Gene Therapy. The QA Operational Support Representative will guide quality activities, from document control to inspections readiness, to ensure GMP compliance for clinical and commercial supply.

We seek a candidate with a strong QA background in pharma manufacturing, capable of mentoring teams and driving data integrity across processes, equipment validation, and change control