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Form of work Part time - role is part time 20-25 hours/week and will be fully remote.
Duties: Ensure the quality and compliance of Allogene's clinical activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations Prepare and conduct or assist/oversee contract auditors for GxP audits per established strategiesAudit, as required, and provide audit results to stakeholders and support process improvement activities asa subject matter expert (SME) in GCP/GPvP/GLPSupport the development of internal systems for the maintenance of internal audit files, Tracking Log and related Clinical QA outputs/summaries/metrics.Establish contract agreements and Statement of Works (SOWs) with Clinical QA consultants, according to the internal process. with Allogene Legal inputConduct/oversee Clinical QA review of draft protocols; Informed Consent Forms, aggregate safety reports, clinical study reports and other clinical trial specific documents, when requestedConduct/oversee risk-based audits of service providers, internal systems and clinical investigators involved with Allogene clinical trial programsConduct/oversee of regulatory training for GCP/GPvP/GLP as needed Conduct the review of clinical trial related SOPsSupport efforts to enhance and establish a corporate-wide Quality Management System (QMS)Lead in the inspection readiness activities; attend clinical trial team meetings, provide Clinical QA advice, as necessary to clinical teams and functions Maintain working knowledge of FDA, EU and other global regulations and guidance governing GCP/GPvP/GLP.Maintain file organization within the Clinical Quality Assurance Department Other duties as assigned Skills: Excellent understanding of Clinical Development ProcessExperience writing and reviewing SOPs which support clinical trialsGood understanding of FDA GCP and ICH regulatory requirements and implementationGood knowledge of Computer System Validation (CSV) in association with GCP/GPvP/GLP auditsGood knowledge of clinical laboratory requirements and method validationEffective communication (verbal and written)Strong interpersonal skills, team player, and flexible without compromising qualityAbility to manage multiple projects in a dynamic environment and ability to meet fast-track timelinesAn ability to be productive and successful in an intense work environmentExperience with participating in global regulatory inspections Education: Minimum Bachelor's degree in a healthcare or scientific-related discipline with 8 years for experience in GCP/GPvP/GLP quality assurance experience in a pharmaceuticals or biotechnology industry (an equivalent combination of experience andeducation may be considered)
Duties: Ensure the quality and compliance of Allogene's clinical activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations Prepare and conduct or assist/oversee contract auditors for GxP audits per established strategiesAudit, as required, and provide audit results to stakeholders and support process improvement activities asa subject matter expert (SME) in GCP/GPvP/GLPSupport the development of internal systems for the maintenance of internal audit files, Tracking Log and related Clinical QA outputs/summaries/metrics.Establish contract agreements and Statement of Works (SOWs) with Clinical QA consultants, according to the internal process. with Allogene Legal inputConduct/oversee Clinical QA review of draft protocols; Informed Consent Forms, aggregate safety reports, clinical study reports and other clinical trial specific documents, when requestedConduct/oversee risk-based audits of service providers, internal systems and clinical investigators involved with Allogene clinical trial programsConduct/oversee of regulatory training for GCP/GPvP/GLP as needed Conduct the review of clinical trial related SOPsSupport efforts to enhance and establish a corporate-wide Quality Management System (QMS)Lead in the inspection readiness activities; attend clinical trial team meetings, provide Clinical QA advice, as necessary to clinical teams and functions Maintain working knowledge of FDA, EU and other global regulations and guidance governing GCP/GPvP/GLP.Maintain file organization within the Clinical Quality Assurance Department Other duties as assigned Skills: Excellent understanding of Clinical Development ProcessExperience writing and reviewing SOPs which support clinical trialsGood understanding of FDA GCP and ICH regulatory requirements and implementationGood knowledge of Computer System Validation (CSV) in association with GCP/GPvP/GLP auditsGood knowledge of clinical laboratory requirements and method validationEffective communication (verbal and written)Strong interpersonal skills, team player, and flexible without compromising qualityAbility to manage multiple projects in a dynamic environment and ability to meet fast-track timelinesAn ability to be productive and successful in an intense work environmentExperience with participating in global regulatory inspections Education: Minimum Bachelor's degree in a healthcare or scientific-related discipline with 8 years for experience in GCP/GPvP/GLP quality assurance experience in a pharmaceuticals or biotechnology industry (an equivalent combination of experience andeducation may be considered)
