Associate Director, Clinical Quality Assurance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. The Associate Director, Clinical Quality Assurance (CQA) will 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 all regulatory requirements. Key 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. Lead process improvement initiatives across QA and broader organization. Provide mentorship and leadership to QA staff; may include direct management 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. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (View email address on click.appcast.io), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL). Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $117,000 - $189,200. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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