Senior Clinical Quality Operations Manager

Eikon Therapeutics • Jersey City, NJ

11h • Hybrid

About The Position

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.

Requirements

• Minimum of 8+ years of related experience with a Bachelor’s degree; or 6+ years with a post graduate degree.
• In-depth knowledge of GCP, ICH E6(R3) guidelines and other relevant regulations and guidelines.
• Demonstrated experience with CAPA management, including root cause analysis, preventive action development, translating CAPA findings into operational changes and tracking commitments to completion.
• Experience with risk management tools and quality planning in clinical development, including Quality by Design and risk-based approaches.
• Proven ability to work cross-functionally with clinical operations, quality assurance, regulatory, data management, and other clinical development teams in a matrixed environment.
• Superior oral and written communication skills in an international environment with the ability to influence at all levels.
• Excellent 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.

Nice To Haves

• Additional certifications such as lean six sigma or PMP are preferred but not required.
• Experience with Veeva or similar document and quality management systems is a plus.

Responsibilities

• 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 portfo lio, 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.
• 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.
• 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.
• Provides RACT completion status, quality plan metrics, and other operational data to CQA for inclusion in GCP Quality Council meetings.
• Assesses and provides input to strengthen company programs/strategies with an aim to increase inspection readiness.
• Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.

Benefits

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

What This Job Offers

• Job Type: Full-time
• Career Level: Senior