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Job Title:
Director, Quality Assurance – GCP Position Overview: The Director of Quality Assurance (GCP) will provide strategic leadership and oversight of all clinical quality activities to ensure compliance with applicable regulatory requirements, company SOPs, and Good Clinical Practice (GCP) guidelines. This role will lead quality operations across clinical programs, ensuring inspection readiness, driving continuous improvement, and fostering a culture of quality across the organization. Key Responsibilities: Provide oversight of SOPs, policies, and controlled documents to ensure alignment with GCP and regulatory expectations. Lead Supplier Qualification activities, including qualification audits and ongoing performance monitoring of CROs, laboratories, and other clinical vendors. Manage and oversee Investigations, Root Cause Analyses (RCAs), Corrective and Preventive Actions (CAPAs), and Change Controls. Lead and conduct domestic and global GCP audits (investigator sites, vendors, internal systems) for clinical trials across Phases I–IV. Audit clinical trial systems and deliverables, including eCRF, databases, pharmacokinetics (PK), statistics (SAP, TLFs, datasets, CDISC packages), biostatistics, medical writing, pharmacovigilance, and data management outputs. Conduct periodic reviews of study documentation to ensure accuracy, completeness, and compliance. Prepare investigator sites and vendors for regulatory inspections, ensuring readiness at all times. Oversee and coordinate global inspection readiness activities, including mock inspections, training, and process improvements. Host and manage regulatory inspections, including leading Front Room and Back Room activities. Provide strategic input and guidance to clinical teams on GCP compliance throughout the lifecycle of studies. Collaborate cross-functionally with Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Regulatory Affairs to resolve quality issues and implement improvements. Qualifications & Experience: Bachelor’s degree in Life Sciences or related field; advanced degree preferred. Extensive experience in clinical quality assurance with a strong GCP focus, including international experience. Proven track record of successfully managing regulatory inspections and leading global inspection readiness initiatives. Strong knowledge of ICH GCP, FDA, EMA, and other international regulatory requirements. Expertise in auditing investigator sites, CROs, laboratories, and internal systems. Excellent leadership, communication, and interpersonal skills with the ability to influence at all levels. eireann.evans@meetlifesciences.com Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
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Director, Quality Assurance – GCP Position Overview: The Director of Quality Assurance (GCP) will provide strategic leadership and oversight of all clinical quality activities to ensure compliance with applicable regulatory requirements, company SOPs, and Good Clinical Practice (GCP) guidelines. This role will lead quality operations across clinical programs, ensuring inspection readiness, driving continuous improvement, and fostering a culture of quality across the organization. Key Responsibilities: Provide oversight of SOPs, policies, and controlled documents to ensure alignment with GCP and regulatory expectations. Lead Supplier Qualification activities, including qualification audits and ongoing performance monitoring of CROs, laboratories, and other clinical vendors. Manage and oversee Investigations, Root Cause Analyses (RCAs), Corrective and Preventive Actions (CAPAs), and Change Controls. Lead and conduct domestic and global GCP audits (investigator sites, vendors, internal systems) for clinical trials across Phases I–IV. Audit clinical trial systems and deliverables, including eCRF, databases, pharmacokinetics (PK), statistics (SAP, TLFs, datasets, CDISC packages), biostatistics, medical writing, pharmacovigilance, and data management outputs. Conduct periodic reviews of study documentation to ensure accuracy, completeness, and compliance. Prepare investigator sites and vendors for regulatory inspections, ensuring readiness at all times. Oversee and coordinate global inspection readiness activities, including mock inspections, training, and process improvements. Host and manage regulatory inspections, including leading Front Room and Back Room activities. Provide strategic input and guidance to clinical teams on GCP compliance throughout the lifecycle of studies. Collaborate cross-functionally with Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Regulatory Affairs to resolve quality issues and implement improvements. Qualifications & Experience: Bachelor’s degree in Life Sciences or related field; advanced degree preferred. Extensive experience in clinical quality assurance with a strong GCP focus, including international experience. Proven track record of successfully managing regulatory inspections and leading global inspection readiness initiatives. Strong knowledge of ICH GCP, FDA, EMA, and other international regulatory requirements. Expertise in auditing investigator sites, CROs, laboratories, and internal systems. Excellent leadership, communication, and interpersonal skills with the ability to influence at all levels. eireann.evans@meetlifesciences.com Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
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