layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Clinical Quality Operations Manager at Eikon Therapeutics

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 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 assigned clinical programs, 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 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, working 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 for assigned studies, 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.
Assesses and provides input to strengthen company programs/strategies with an aim to increase inspection readiness.
Facilitates and/or supports remediation, prevention, and process improvement activities, including training, as needed.

Clinical Quality Operations Manager

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