DPEM QA Data Steward

Eli Lilly and Company; Indianapolis (IN); On-site; USD 63,000 - 163,000; Full time

Job summary

Eli Lilly and Company is seeking a DPEM QA Data Steward to ensure the safety and efficacy of drug products. This role involves managing quality systems, mentoring staff, and supporting compliance. The ideal candidate will have a relevant degree and extensive experience in quality assurance within the pharmaceutical industry.

Benefits

Bonus potential

401(k)

Health insurance

Paid time off

Wellness programs

Qualifications

• 5+ years in QA with DPEM experience.
• Experience as a Power User or Data Steward.
• Knowledge of operations business processes.

Responsibilities

• Support implementation and maintenance of computerized quality systems.
• Manage quality master data in SAP.
• Lead and mentor DPEM personnel on quality systems.

Skills

Quality Assurance

Data Stewardship

Technical Writing

Regulatory Inspection Readiness

Education

Bachelor’s degree in a relevant field

Tools

SAP

TrackWise

Veeva Q Docs

Darwin

Job description

Join to apply for the DPEM QA Data Steward role at Eli Lilly and Company

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We prioritize our work and people.

Drug Product External Manufacturing (DPEM) Quality Assurance ensures the safety and efficacy of drug products worldwide by overseeing contract manufacturers and alliance partners, covering all process steps from selection to termination.

Responsibilities

• Support the implementation, validation, and maintenance of computerized quality systems for DPEM.
• Serve as Power User for QA IT systems including SAP, TrackWise, Veeva Q Docs, & Darwin.
• Create and manage quality master data in SAP, ensuring data integrity and accuracy.
• Lead, mentor, and coach DPEM personnel on quality systems.
• Manage DPEM compliance documents, including specifications and procedures.
• Build relationships with Global Quality and IT teams.
• Support continuous improvement of quality systems.
• Review and approve GMP documents to ensure quality attributes are met.
• Participate in and support inspections, including self-led and regulatory.

Basic Qualifications

• Bachelor’s degree in a relevant field or equivalent experience.
• 5+ years in QA with DPEM experience and familiarity with SAP, DEEVA, or similar software.
• Experience as a Power User or Data Steward for relevant systems.
• Knowledge of operations business processes like batch disposition and materials management.
• Experience with equipment qualification and process validation.
• Experience with SAP or similar inventory systems.
• Experience with device and parenteral product materials.

Additional Skills/Preferences

• Experience in pharmaceutical or medical device QA roles.
• GMP data stewardship experience.
• Proficiency with GMP computer systems including Lab, CAPA, and Document Control systems.
• Strong technical writing skills.
• Commitment to safety and supporting HSE goals.
• Regulatory inspection readiness and experience.

Additional Information

• Shift is days; flexibility and off-hours support may be needed.
• Some travel (<10%) and on-site presence (minimum 4 days/week); relocation available.

Lilly is committed to diversity and inclusion, providing accommodations for applicants with disabilities. For assistance, complete the accommodation request form on our website.

We are an equal opportunity employer, welcoming applicants regardless of age, race, gender, or other protected statuses.

Our employee resource groups (ERGs) support diverse communities and include groups for various cultural, identity, and professional interests.

Compensation varies based on education, experience, and location, with an anticipated range of $63,000 - $162,800. Benefits include bonus potential, 401(k), health insurance, paid time off, and wellness programs.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Information Technology
• Industry: Pharmaceutical Manufacturing

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