Senior Clinical Quality Operations Manager
Eikon TherapeuticsJersey City, New Jersey, United States · Posted 16 days agoDescription
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
In partnership with the Director of Process Management for Clinical Research & Development, the Senior Clinical Quality Operations Manager (Sr. CQOM) is accountable for the execution of operational quality management and inspection readiness activities across Eikon's clinical development programs, to whom this role reports. The Sr. CQOM oversees clinical quality operations across assigned clinical programs, embedding quality-by-design principles, risk-based quality plans, and vendor oversight into Eikon's clinical trials. In partnership with Clinical Quality Assurance (CQA), the CQOM drives disciplined execution of quality plans and operational standards, enabling study teams to be inspection ready. This includes ensuring consistent execution of quality-by-design (QBD) principles across assigned clinical development programs and facilitating identification of Critical to Quality (CtQs) factors and associated risk assessments, establishing, and actively maintaining study-specific quality plans throughout the study lifecycle using a risk-based approach. The Sr. CQOM is accountable for the overall strategy to maintain inspection readiness through disciplined execution of risk assessments, quality plans and operational standards, in collaboration with Clinical Quality Assurance (CQA) on inspection preparation, management and follow-up activities.The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world-class in-house clinical study management.
This role requires onsite presence at minimum 3 days per week to support effective management, operational excellence, and high-performance delivery of clinical studies and expected team growth & collaboration.
About You
You are a collaborative, hands-on leader who enjoys working alongside clinical study teams to strengthen consistency, embed quality and drive disciplined trial execution. You bring credibility through deep knowledge of GCP and strong clinical operations expertise and are energized by cross-functional partnership. You are excited about the opportunity to shape a new function in a growing organization.
What You'll Do
- Ensures consistent execution of 'quality by design' principles in assigned clinical trials. Reviews Risk Assessment and Categorization Tools (RACTs), quality plans, and study-specific procedures with Study Management Teams to confirm accuracy, compliance with Sponsor requirements, and inspection-readiness.
- Facilitates TA-level review of CtQs, quality plans and risk mitigation approaches to identify inconsistencies, emerging signals, and trends and to provide relevant feedback to the Head of Clinical Study Management and Director of Process Management for Clinical R&D, as appropriate.
- Works with Clinical R&D peers to analyze data across Eikon's clinical trials to identify signals and trends and translate findings into actionable process improvement strategies.
- In partnership with the Director of Process Management for Clinical R&D, the Head of Clinical Data Analytics and Reporting and the Head of Clinical Study Management, builds proficiency in leveraging technology and data to recognize and respond to new and emerging risks across the clinical portfolio, including how GCP applies to digital data management and novel trial technology.
- Partners with cross-functional study teams to ensure vendor and CRO performance is documented in vendor and CRO oversight plans and monitored against quality expectations, escalating compliance, or inspection-readiness risks to Clinical R&D functional area Heads, as necessary.
- Builds and enables effective working relationships with key stakeholders to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with Clinical R&D Clinical Quality Assurance (CQA) and acting as the link between Clinical R&D functional areas, clinical study teams, enterprise business functions, and regional study management.
- Contributes to the standardization of Clinical Quality Operations procedures, tools, and templates to ensure consistency and seamless progression throughout the study lifecycle.
Inspection Preparation and Management
- Maintains current, in-depth knowledge of global GCP inspection practices – including requirements from FDA, EMA, MHRA, and other established and emerging authorities – to effectively support GCP inspections worldwide. May serve as point of contact for a specific regulatory area (e.g., FDA, EMA, NMPA). Is responsible for monitoring, interpreting, and communicating relevant regulatory developments.
- Maintains current awareness of filing schedules, potential future inspections, and ongoing inspection preparation activities.
- Supports CQA in developing, updating, and maintaining GCP inspection procedures and guidelines within Clinical Development Operations and Clinical R&D functional areas.
- Contributes to the development and/or revision of Eikon policies, SOPs, and training materials.
- Ensures the operational foundation supports favorable inspection outcomes and that study teams execute consistently against study plans and operational standards.
- Partners with CQA to ensure the Clinical R&D functional areas are fully informed and prepared to support Regulatory Health Authority inspections led by CQA, worldwide.
- Escalates potentially significant compliance risks/impact to Clinical R&D functional area Heads, as necessary.
CAPA Management Support
- Leads CAPA implementation for CQA-sponsored internal audits, partnering with study teams and functions to translate findings into process changes.
- For external audits and Regulatory Health Authority inspections, partners with study teams to develop CAPA responses and implement CQA-approved corrective actions requiring process, tool, or workflow changes.
- Coordinates education and training for study teams on process changes resulting from CAPAs, ensuring changes are understood, adopted, and sustained in practice.
Other Activities
- Provides RACT completion status, quality plan metrics, and other operational data to CQA for inclusion in GCP Quality Council meetings.
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