Senior Clinical Quality Assurance Lead, GCP

Eli Lilly and Company; United States; Remote; USD 117,000 - 189,000; Full time

Benefits offered by this job

401(k) plan

Pension

Medical, dental, vision benefits

Well-being benefits

Job summary

Lilly seeks an Associate Director, Clinical Quality Assurance to oversee GCP-focused QA for Centessa-sponsored trials, ensuring compliance with global regulations and ICH guidelines. You will lead QA programs, audits, and inspection readiness across sites, CROs, and vendors.

The role requires a senior QA mindset, collaboration with cross-functional teams, and a focus on risk management and CAPA resolution in a fast-paced environment.

Qualifications

• BS or higher in Life Sciences, Chemistry, Pharmacy, or related field.
• 8–10 years of experience in pharmaceutical quality roles.
• Experience with document control software (ZenQMS, Veeva Vault, MasterControl).

Responsibilities

• Lead and maintain GCP QA programs, policies, and procedures.
• Serve as primary GCP QA expert and point of contact.
• Ensure clinical programs comply with global health authority regulations and ICH guidelines.
• Provide QA oversight for protocols, ICFs, CSRs, and other trial documents.
• Monitor evolving GCP regulations and communicate impact to stakeholders.
• Develop and execute global GCP audit strategies and annual plans.
• Conduct audits of investigator sites, CROs, suppliers, systems, and documents.
• Prepare audit reports, evaluate CAPAs, and ensure follow-up.
• Lead inspection readiness activities and support regulatory inspections (FDA, EMA, MHRA).
• Mentor and lead QA staff; may include direct management.

Skills

GCP compliance

QA leadership

Regulatory liaison

Education

BS or higher in Life Sciences, Chemistry, Pharmacy, or related field

Tools

ZenQMS

Veeva Vault

MasterControl

Job description

Lilly seeks an Associate Director, Clinical Quality Assurance to oversee GCP-focused QA for Centessa-sponsored trials, ensuring compliance with global regulations and ICH guidelines. You will lead QA programs, audits, and inspection readiness across sites, CROs, and vendors.

The role requires a senior QA mindset, collaboration with cross-functional teams, and a focus on risk management and CAPA resolution in a fast-paced environment.