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Salary: USD 143,000 - 173,250 / annual
Eikon Therapeutics, a biopharmaceutical company founded on Nobel Prize-winning innovations, is seeking a Clinical Quality Operations Manager to drive operational excellence across its clinical development portfolio. Reporting to the Director of Process Management for Clinical Research & Development, you will oversee clinical quality operations across assigned clinical programs, embedding quality-by-design (QbD) principles, risk-based quality plans, and vendor oversight into clinical trials.
Key responsibilities include:
**Core Operations & Quality Management:**
Ensure consistent execution of quality-by-design principles across assigned clinical studies. Review Risk Assessment and Categorization Tools (RACTs), quality plans, and study-specific procedures with Study Management Teams to confirm accuracy, compliance, and inspection-readiness. Facilitate identification of Critical to Quality (CtQ) factors and associated risk assessments. Analyze data across clinical trials to identify signals and trends, translating findings into actionable process improvement strategies. Partner with cross-functional teams to leverage technology and data to recognize and respond to emerging risks, including how GCP applies to digital data management and novel trial technology.
**Vendor & CRO Oversight:**
Ensure vendor and CRO performance is documented in oversight plans and monitored against quality expectations. Escalate compliance or inspection-readiness risks to Clinical R&D functional area heads as necessary.
**Inspection Preparation & Regulatory Compliance:**
Maintain current, working knowledge of global GCP inspection practices from FDA, EMA, MHRA, and other authorities. May serve as point of contact for specific regulatory areas. Monitor filing schedules and potential future inspections. Support Clinical Quality Assurance (CQA) in developing and maintaining GCP inspection procedures and guidelines. Contribute to development and revision of company policies, SOPs, and training materials. Ensure the operational foundation supports favorable inspection outcomes.
**CAPA Management:**
Lead CAPA implementation for CQA-sponsored internal audits for assigned studies. Partner with study teams to develop CAPA responses for external audits and regulatory inspections. Coordinate education and training for study teams on process changes resulting from CAPAs.
**Cross-Functional Collaboration:**
Build and enable effective working relationships with key stakeholders across Clinical R&D, clinical study teams, enterprise business functions, and regional study management. Contribute to standardization of Clinical Quality Operations procedures, tools, and templates.
This role requires onsite presence at minimum 3 days per week in Millbrae, CA or Jersey City, NJ offices to support effective management and high-performance delivery of clinical studies.
**Requirements:**
- Minimum 6+ years of related experience with a Bachelor's degree, OR 4+ years of experience with a post-graduate degree
- Strong working knowledge of GCP, ICH E6(R3) guidelines, and other relevant regulations
- Experience with CAPA management, including root cause analysis, preventive action development, and tracking commitments to completion
- Experience with risk management tools and quality planning in clinical development, including Quality by Design and risk-based approaches
- Demonstrated ability to work cross-functionally in a matrixed environment with clinical operations, quality assurance, regulatory, data management, and other clinical development teams
- Strong oral and written communication skills in an international environment with ability to influence at all levels
- Strong teamwork and leadership skills, including conflict resolution expertise
- Ability to analyze, interpret, and solve complex problems
- Ability to think strategically and objectively while applying creativity and innovation
- Ability to synthesize findings and deliver lessons learned
- Experience with Veeva or similar document and quality management systems is a plus
- Additional certifications such as Lean Six Sigma or PMP are preferred but not required
