CSV Quality Process Lead for GxP Systems

Lilly; Indianapolis (IN); On-site; USD 117,000 - 172,000; Full time

Benefits offered by this job

401(k)

Pension

Medical/Dental/Vision

Vacation benefits

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a CSV Common Process Lead to serve as the enterprise SME and quality oversight lead for GxP computerized system lifecycle processes. You will guide change control, deviations/CAPA, periodic review, retirement/decommissioning, and regulatory alignment across GISQ and Tech@Lilly, while supporting inspections and driving process improvements.

The role requires 5+ years in CSV/GxP QMS, strong regulatory knowledge, and demonstrated executive-level

Qualifications

• Bachelor degree in a science, engineering, computer science/systems, or pharmaceutical-related field; or equivalent experience.
• 5+ years of demonstrated expertise in Computer System Validation and computerized system lifecycle management, with strong working knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, data integrity guidance, and related global regulatory expectations.
• 5+ years of demonstrated expertise with GxP QMS processes for computerized systems (e.g., change control, deviation/CAPA, periodic review, retirement/decommissioning), including authoring or owning controlled procedures.
• Prior role experience holding delegated quality authority: interpreting requirements, approving exceptions, and accepting or escalating risk.
• Prior role experience supporting or leading health authority inspections and audits, including drafting and defending the company position on CSV practices.
• Demonstrated ability to contribute and influence at the Executive Leadership level.
• Strong analytical and problem-solving abilities, including the ability to interpret systemic performance trends and direct corrective action.
• Demonstrated strong oral and written communication, interpersonal interaction skills, and ability to influence and collaborate.
• Proficiency with IT systems development life cycle and demonstrated ability to right-size validation based upon risk.
• Ability to focus across multiple processes (end-to-end viewpoint).

Responsibilities

Skills

CSV lifecycle knowledge

GxP QMS expertise

Change control

Deviations & CAPA

Regulatory inspections experience

Executive leadership influence

Analytical problem solving

Communication skills

IT lifecycle proficiency

End-to-end focus

Education

Bachelor degree in science/engineering/CS or pharm field

Equivalent experience

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks a CSV Common Process Lead to serve as the enterprise SME and quality oversight lead for GxP computerized system lifecycle processes. You will guide change control, deviations/CAPA, periodic review, retirement/decommissioning, and regulatory alignment across GISQ and Tech@Lilly, while supporting inspections and driving process improvements.

The role requires 5+ years in CSV/GxP QMS, strong regulatory knowledge, and demonstrated executive-level