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Associate Director – Clinical Quality Assurance
Eli Lilly and Company. Lead and maintain GCP QA programs, policies, and procedures .
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- 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 impacts to stakeholders
- Develop and execute global GCP audit strategies and annual plans
- Conduct and manage audits of investigator sites, CROs, suppliers, systems, and documents
- Prepare audit reports, evaluate CAPAs, and ensure effective follow-up
- Lead inspection readiness activities and support FDA, EMA, MHRA, and other regulatory inspections
- Partner with cross-functional teams and represent CQA on study teams
- Contribute to protocol design and risk management
- Collaborate on clinical quality procedures, forms, and templates
- Identify compliance risks and implement mitigation strategies
- Investigate quality issues, perform root cause analyses, and drive CAPA resolution
- Prepare and present KPIs, metrics, and audit status updates to leadership
- Develop and maintain GCP-related SOPs, training materials, and quality metrics
- Lead process improvement initiatives across QA and the broader organization
- Provide mentorship and leadership to QA staff, potentially including direct management
Requirements
What you’ll need- 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 such as ZenQMS, Veeva Vault, or MasterControl required
- Knowledge of global health authority regulations, ICH guidelines, GCP, and industry standards
Benefits
Comp & perks- Company bonus depending, in part, on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision, and prescription drug benefits
- Healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
- Employee resource groups and support networks