Senior Clinical Quality Consultant

Provide sponsor-side Clinical Quality and GCP oversight for clinical trials, including vendor quality, audit and inspection readiness, deviations, investigations, and CAPA. Remote role aligned to Pacific Time, reporting to the Director of GCP Quality.

Clinical QualityContractRemoteUnited States (PST hours)

Posted September 15, 2026

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Responsibilities

Provide Clinical Quality and GCP support to assigned clinical trials, including document review, system, project, and study-level risk assessment, and timely identification and resolution of potential or realized noncompliance.
Ensure each clinical trial is conducted in accordance with applicable regulations, ICH GCP, the approved protocol, study plans, governance documents, and sponsor standard operating procedures.
Support management of the quality system, including deviations, investigations, corrective and preventive actions, and ongoing quality monitoring across internal teams and external partners such as CROs, clinical sites, and vendors.
Provide quality oversight of clinical vendors from a quality-assurance perspective, including contract research organizations and clinical or bioanalytical laboratories.
Review audit reports from clinical vendors, investigator sites, and internal audits; review CAPA responses to confirm root causes are addressed; escalate audit or inspection risks; and support inspection-readiness activities.
Lead or support quality event management: deviation review, classification, risk assessment, and disposition; timely investigations with robust root cause analysis; effective CAPA development and management; and escalation of quality issues to the Director of GCP Quality.
Analyze and report study-level quality trends and provide periodic or ad hoc quality status reports to relevant leadership.
Provide subject-matter expertise to GxP functional groups and collaborate to prevent or mitigate system- and study-level risks.
Educate stakeholders on regulatory expectations, influence positive quality practices in daily trial activities, and conduct formal GCP training as required.
Perform other duties as assigned by the Director of GCP Quality.

Required qualifications

Bachelor’s degree in a life science discipline or an equivalent field such as nursing, pharmacy, or biotechnology.
At least seven years of progressively responsible clinical quality assurance experience within a sponsor environment, including the ability to navigate complex clinical designs and protocols.
Demonstrated independent support of cross-functional study execution teams, including oversight of clinical vendors and vendor quality event management through trial start-up, conduct, and closeout.
Ability to perform independently with minimal supervision; self-directed, detail-oriented, and capable of sound quality decision-making.
Pragmatic, risk-based approach to clinical trial oversight, with experience providing project- and study-level risk management guidance.
Experience independently reviewing key clinical trial documents and providing regulatory compliance feedback, including protocols and amendments, informed consent forms, investigator brochures, development safety update reports, clinical study reports, study plans, and manuals.
Demonstrated ability to lead root cause investigations and to develop and manage corrective and preventive actions.
Experience as a lead or independent auditor for clinical vendor qualification audits, investigator site audits, internal audits, trial master file audits, and clinical study report audits.
Familiarity with electronic quality management systems such as Veeva and MasterControl.
Ability to build transparent, cooperative relationships and present issues clearly to audiences at any organizational level.
Ability to influence colleagues using regulatory expectations, GCP requirements, and relevant professional experience.
Strong prioritization skills, a record of delivering assignments on time, and willingness to raise concerns when line-management assistance is needed.

Preferred qualifications

Ability to support preparation for anticipated inspections following market authorization applications, including NDA, BLA, and MAA submissions.
Certification in an applicable clinical quality assurance area, such as GCP or auditing.
Experience authoring or reviewing policies, standard operating procedures, work instructions, and audit reports.
Experience establishing quality agreements with clinical vendors or service providers.
Experience developing and implementing quality-related KPIs.
Knowledge of serious adverse event reporting workflows and regulatory requirements, or prior experience overseeing a pharmacovigilance vendor.
Oncology therapeutic-area experience.

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Senior Clinical Quality Consultant

Clinical QualityContractRemoteUnited States (PST hours)

Posted September 15, 2026

Responsibilities

Provide Clinical Quality and GCP support to assigned clinical trials, including document review, system, project, and study-level risk assessment, and timely identification and resolution of potential or realized noncompliance.

Ensure each clinical trial is conducted in accordance with applicable regulations, ICH GCP, the approved protocol, study plans, governance documents, and sponsor standard operating procedures.

Support management of the quality system, including deviations, investigations, corrective and preventive actions, and ongoing quality monitoring across internal teams and external partners such as CROs, clinical sites, and vendors.

Provide quality oversight of clinical vendors from a quality-assurance perspective, including contract research organizations and clinical or bioanalytical laboratories.

Review audit reports from clinical vendors, investigator sites, and internal audits; review CAPA responses to confirm root causes are addressed; escalate audit or inspection risks; and support inspection-readiness activities.

Lead or support quality event management: deviation review, classification, risk assessment, and disposition; timely investigations with robust root cause analysis; effective CAPA development and management; and escalation of quality issues to the Director of GCP Quality.

Analyze and report study-level quality trends and provide periodic or ad hoc quality status reports to relevant leadership.

Provide subject-matter expertise to GxP functional groups and collaborate to prevent or mitigate system- and study-level risks.

Educate stakeholders on regulatory expectations, influence positive quality practices in daily trial activities, and conduct formal GCP training as required.

Perform other duties as assigned by the Director of GCP Quality.

Required qualifications

Bachelor’s degree in a life science discipline or an equivalent field such as nursing, pharmacy, or biotechnology.

At least seven years of progressively responsible clinical quality assurance experience within a sponsor environment, including the ability to navigate complex clinical designs and protocols.

Demonstrated independent support of cross-functional study execution teams, including oversight of clinical vendors and vendor quality event management through trial start-up, conduct, and closeout.

Ability to perform independently with minimal supervision; self-directed, detail-oriented, and capable of sound quality decision-making.

Pragmatic, risk-based approach to clinical trial oversight, with experience providing project- and study-level risk management guidance.

Experience independently reviewing key clinical trial documents and providing regulatory compliance feedback, including protocols and amendments, informed consent forms, investigator brochures, development safety update reports, clinical study reports, study plans, and manuals.

Demonstrated ability to lead root cause investigations and to develop and manage corrective and preventive actions.

Experience as a lead or independent auditor for clinical vendor qualification audits, investigator site audits, internal audits, trial master file audits, and clinical study report audits.

Familiarity with electronic quality management systems such as Veeva and MasterControl.

Ability to build transparent, cooperative relationships and present issues clearly to audiences at any organizational level.

Ability to influence colleagues using regulatory expectations, GCP requirements, and relevant professional experience.

Strong prioritization skills, a record of delivering assignments on time, and willingness to raise concerns when line-management assistance is needed.

Preferred qualifications

Ability to support preparation for anticipated inspections following market authorization applications, including NDA, BLA, and MAA submissions.

Certification in an applicable clinical quality assurance area, such as GCP or auditing.

Experience authoring or reviewing policies, standard operating procedures, work instructions, and audit reports.

Experience establishing quality agreements with clinical vendors or service providers.

Experience developing and implementing quality-related KPIs.

Knowledge of serious adverse event reporting workflows and regulatory requirements, or prior experience overseeing a pharmacovigilance vendor.

Oncology therapeutic-area experience.