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Eikon Therapeutics, a biopharmaceutical company founded on Nobel Prize-winning innovations, is seeking a Senior Clinical Quality Operations Manager to drive operational excellence across clinical development programs. Reporting to the Director of Process Management for Clinical Research & Development, you will oversee clinical quality operations, embedding quality-by-design (QBD) principles, risk-based quality plans, and vendor oversight into clinical trials.
Key responsibilities include:
- Execute operational quality management and inspection readiness activities across assigned clinical programs
- Establish and maintain study-specific quality plans using a risk-based approach throughout the study lifecycle
- Facilitate identification of Critical to Quality (CtQ) factors and associated risk assessments
- Partner with Clinical Quality Assurance (CQA) to drive disciplined execution of quality standards and enable study teams to be inspection-ready
- Develop and maintain overall strategy for inspection readiness through risk assessments, quality plans, and operational standards
- Collaborate with cross-functional Clinical Research & Development teams to ensure successful study completion within timelines and budget
- Support team growth and high-performance delivery of clinical studies
You bring deep knowledge of GCP (Good Clinical Practice), strong clinical operations expertise, and a collaborative, hands-on leadership style. You are energized by cross-functional partnership and excited about shaping a new function in a growing organization. The role requires onsite presence at minimum 3 days per week to support effective management and operational excellence.
