Avidity Biosciences
Associate Director, GCP Quality Assurance
Avidity Biosciences, San Diego, California, United States, 92189
Company Overview
Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.Position Overview
The Associate Director, GCP Quality Assurance, reporting to the Director of Quality Assurance, will manage the clinical quality function by supporting and providing oversight of clinical trials and clinical activities, establish and manage clinical quality systems, and ensure GCP compliance. The candidate will be hands-on and actively involved in executing GCP QA strategy, and support GCP compliance and alliance activities with vendors and business partners. The personnel will collaborate cross-functionally with various departments within the organization, and ensure effective communication and constructive working relationships with colleagues and business partners to enable global development of Avidity therapeutics.Responsibilities
Develop, implement, and maintain GCP quality management systems, policies, and SOPsEnsure GCP compliance of ongoing clinical trialsConduct quality control reviews of clinical protocols, documents, and records, including regulatory filingIdentify compliance risks and implement risk mitigation, as applicable.Monitor, track, and trend GCP non-conformances, deviations, and CAPAs and communicate to managementManage GCP audit activities, internal and external, including conducting clinical vendor qualifications and audits, conducting investigational site audits, and ensuring completion of corrective actionsEnsure clinical documentation in support of TMF is reviewed and archived appropriatelySupport investigational product complaints and ensure complianceSupport inspection readiness of clinical programsPerform other duties as requiredQualifications
Minimum Bachelor’s degree in a relevant scientific discipline or equivalentMinimum of 6 years of pharmaceutical industry experience in GCP-QAExtensive knowledge of GCP regulations, ICH Guidelines, FDA regulations and GuidanceGood working knowledge of GLP in support of non-clinical is recommendedExperience working with CROs, vendor selection, and managementQA experience in Phase 1-3 clinical trialsProven ability to thrive and enable success in a cross-functional and collaborative environmentStrong communication and interpersonal skillsAbility to multi-task, shift priorities, and work in a fast-paced environmentDetail oriented and well organizedTeam player, professional demeanor, enthusiastic, and self-motivatedTravel 10-20%, as required
#J-18808-Ljbffr
Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.Position Overview
The Associate Director, GCP Quality Assurance, reporting to the Director of Quality Assurance, will manage the clinical quality function by supporting and providing oversight of clinical trials and clinical activities, establish and manage clinical quality systems, and ensure GCP compliance. The candidate will be hands-on and actively involved in executing GCP QA strategy, and support GCP compliance and alliance activities with vendors and business partners. The personnel will collaborate cross-functionally with various departments within the organization, and ensure effective communication and constructive working relationships with colleagues and business partners to enable global development of Avidity therapeutics.Responsibilities
Develop, implement, and maintain GCP quality management systems, policies, and SOPsEnsure GCP compliance of ongoing clinical trialsConduct quality control reviews of clinical protocols, documents, and records, including regulatory filingIdentify compliance risks and implement risk mitigation, as applicable.Monitor, track, and trend GCP non-conformances, deviations, and CAPAs and communicate to managementManage GCP audit activities, internal and external, including conducting clinical vendor qualifications and audits, conducting investigational site audits, and ensuring completion of corrective actionsEnsure clinical documentation in support of TMF is reviewed and archived appropriatelySupport investigational product complaints and ensure complianceSupport inspection readiness of clinical programsPerform other duties as requiredQualifications
Minimum Bachelor’s degree in a relevant scientific discipline or equivalentMinimum of 6 years of pharmaceutical industry experience in GCP-QAExtensive knowledge of GCP regulations, ICH Guidelines, FDA regulations and GuidanceGood working knowledge of GLP in support of non-clinical is recommendedExperience working with CROs, vendor selection, and managementQA experience in Phase 1-3 clinical trialsProven ability to thrive and enable success in a cross-functional and collaborative environmentStrong communication and interpersonal skillsAbility to multi-task, shift priorities, and work in a fast-paced environmentDetail oriented and well organizedTeam player, professional demeanor, enthusiastic, and self-motivatedTravel 10-20%, as required
#J-18808-Ljbffr