Associate Director, Clinical GCP QA Leader

Eli Lilly; United States; On-site; USD 117,000 - 189,000; Full time

Job summary

Lilly is seeking an Associate Director, Clinical Quality Assurance (CQA) to oversee GCP-focused quality assurance for Centessa-sponsored clinical trials (Early to Late Phase), ensuring compliance with global regulations, ICH guidelines, Centessa SOPs, and industry standards.

This role leads daily clinical quality operations, maintains effective quality programs and documentation, and ensures GCP compliance and inspection readiness across regulatory requirements.

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 (e.g., ZenQMS, Veeva Vault, MasterControl) required.

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 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 regulatory inspections (e.g., FDA, EMA, MHRA).
• Partner with cross‑functional teams to ensure compliance.
• Represent CQA on study teams and contribute to protocol design and risk management.
• Collaborate on procedures, forms, and templates related to clinical quality.
• 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.

Skills

QA leadership

GCP knowledge

Regulatory readiness

Education

Bachelor's degree in Life Sciences

Tools

ZenQMS

Veeva Vault

MasterControl

Job description

Lilly is seeking an Associate Director, Clinical Quality Assurance (CQA) to oversee GCP-focused quality assurance for Centessa-sponsored clinical trials (Early to Late Phase), ensuring compliance with global regulations, ICH guidelines, Centessa SOPs, and industry standards.

This role leads daily clinical quality operations, maintains effective quality programs and documentation, and ensures GCP compliance and inspection readiness across regulatory requirements.