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Company

Original Job Post

Crinetics Pharmaceuticals · 2 days ago

Senior Manager, Quality Assurance GCP

San Diego, CA

Full-time

Onsite

Senior Level

$117K/yr - $156K/yr

8+ years exp

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BiotechnologyHealth Care

Hiring Manager

Malcolm Stewart

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Responsibilities

Manage audits and audit finding resolution process.

Manage, oversee, conduct, and report assigned GCP routine audits (internal system/process, TMF, clinical investigator site, vendors, data, and clinical documents).

Manage and perform vendor risk assessments. Generate and maintain annual audit plans; maintain trackers and trend audit findings.

Maintain and archive QA electronic vendor files and audit documentation. Reconcile master vendor tracker and vendor records.

Manage GCP quality agreements. Attend vendor governance and oversight meetings.

Provide GCP guidance and feedback for research and development activities; participate in clinical study team meetings and discuss clinical study related compliance topics. Identify and escalate significant compliance risks to senior management.

Review clinical study documents (protocols, study plans, IB, CSR, etc.) of moderate complexity to provide feedback.

Foster a collaborative environment that supports GCP compliance and continuous improvement; identify and mitigate potential compliance risks.

Review deviations, quality issues, and CAPAs; perform investigations and root cause analysis.

Develop and maintain professional cross-functional and cross-departmental relationships.

Interpret and apply global regulations of moderate complexity.

Identify compliance gaps and develop corrections or improvements.

Support inspection-readiness activities and regulatory inspections.

Develop, modify, and execute SOPs or Work Instructions.

Timely completion of required training.

Manage multiple projects simultaneously.

Develop training materials with minimal support; administer GCP training.

Support other quality driven activities and initiatives.

Qualification

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Supervisory experienceRegulatory interpretationGCP QA auditsVendor managementQMSSOPsInternal auditsDeviationsCAPAsAuditor managementConceptional thinkingRisk-based approachProblem-solvingCollaborationInterpersonalCommunicationOrganizationalPrioritizationDetail-orientedPresentationGLPGVPRegulatory InspectionAuditor Certification