Senior Clinical Quality Operations Manager

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.

About the role

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. 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.

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.

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 Critical to Quality (CtQs) factors, quality plans, and risk mitigation approaches to identify inconsistencies, emerging signals, and trends; provides relevant feedback to leadership.
• 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.
• Builds proficiency in leveraging technology and data to recognize and respond to new and emerging risks across the clinical portfolio, including GCP applications to digital data management and novel trial technology.
• Partners with cross-functional study teams to ensure vendor and CRO performance is documented in oversight plans and monitored against quality expectations, escalating compliance or inspection-readiness risks as needed.
• Builds and enables effective working relationships with key stakeholders to ensure role clarity and business effectiveness, acting as the link between Clinical R&D, clinical study teams, enterprise functions, and regional study management.
• Contributes to the standardization of Clinical Quality Operations procedures, tools, and templates to ensure consistency throughout the study lifecycle.

Inspection Preparation and Management

• Maintains current, in-depth knowledge of global GCP inspection practices (FDA, EMA, MHRA, and other authorities) to support worldwide inspections.
• May serve as point of contact for a specific regulatory area (e.g., FDA, EMA, NMPA).
• Monitors, interprets, and communicates relevant regulatory developments.
• Supports CQA in developing, updating, and maintaining GCP inspection procedures and guidelines.
• Contributes to the development and/or revision of Eikon policies, SOPs, and training materials.
• Ensures operational foundation supports favorable inspection outcomes and consistent execution against study plans and operational standards.
• Partners with CQA to prepare Clinical R&D functional areas for Regulatory Health Authority inspections led by CQA.
• Escalates potentially significant compliance risks/impact to Clinical R&D functional area Heads.

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.
• Coordinates education and training for study teams on process changes resulting from CAPAs, ensuring changes are understood, adopted, and sustained.

Other Activities

• Provides RACT completion status, quality plan metrics, and other operational data to CQA for 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, process improvement, and training as needed.

Requirements

• Minimum of 8+ years of related experience with a Bachelor’s degree; or 6+ years with a postgraduate degree.
• In-depth knowledge of GCP, ICH E6(R3) guidelines, and other relevant regulations.
• Demonstrated experience with CAPA management, including root cause analysis, preventive action development, and translating findings into operational changes.
• 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; think strategically and objectively while applying creativity and innovation.
• Experience with Veeva or similar document and quality management systems is a plus.

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

Pay

The expected salary range for this role is $157,000 to $189,000 depending on skills, competency, and market demand for your expertise.