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Clinical Quality Operations Manager

Eikon Therapeutics
USA
Manager · 6+ years experience
Onsite
$143,000 to $173,250
Discovered 1 weeks ago
GCPCommunication

Full Job Posting

Qualifications

  • Minimum of 6+ years of related experience with a Bachelor's degree; or 4+ years of experience with a post graduate degree. Additional certifications such as lean six sigma or PMP are preferred but not required.
  • Strong working knowledge of GCP, ICH E6(R3) guidelines and other relevant regulations and guidelines.
  • 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.
  • Demonstrated ability to work cross-functionally with clinical operations, quality assurance, regulatory, data management, and other clinical development teams in a matrixed environment.
  • Strong oral and written communication skills in an international environment with the 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.
  • At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
  • 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
  • The expected salary range for this role is $143,000 to $173,250 depending on skills, competency, and the market demand for your expertise.
  • Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
  • We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
  • You are a collaborative, hands-on quality operations professional 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 help 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 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.

Preferred Qualifications

  • Minimum of 6+ years of related experience with a Bachelor's degree; or 4+ years of experience with a post graduate degree. 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.
  • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies

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 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.
  • 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.
  • 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.
  • 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.

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