Invivyd, Inc
Associate Director, Clinical Quality Assurance and Compliance Remote (Northeast
Invivyd, Inc, Jackson, Mississippi, United States
Associate Director, Clinical Quality Assurance and Compliance
Remote (Northeast Preferred) Overview
Invivyd is focused on delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2, with a proprietary platform to assess, monitor, develop, and adapt best-in-class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody in its pipeline. Join a team of innovators who are committed to making a difference and delivering life-saving solutions. Position summary
The primary responsibility of the Associate Director of Clinical Quality Assurance and Compliance is to develop and lead all quality assurance and compliance activities for the clinical development organization. The role is accountable for driving Clinical Quality initiatives to completion in collaboration with Regulatory and Clinical departments and external vendors. It also includes coordinating, controlling, and continuously improving internal QA processes related to clinical development and related activities and systems. The Associate Director will coordinate audits to support GCP, GLP, GVP, and other regulated activities and lead strategies for health authority inspections. The role ensures compliance of clinical trials and development activities with global regulatory standards (including US FDA, ICH, and other international regulators) and oversees clinical inspection readiness for Invivyd’s development programs. Responsibilities
Build the Clinical Quality Assurance and Compliance function and infrastructure to support Invivyd pipeline and related activities Participate on cross-functional team meetings as the Clinical Quality Assurance Subject Matter Expert (SME) Create, implement, and maintain efficient, phase-appropriate, and compliant GCP, GLP, and GVP systems and policies/procedures Partner with stakeholders to develop and maintain cross-functional SOPs, policies, procedures, and systems aligned with corporate objectives Support a risk-based approach to oversight of clinical trials using quality by design and quality risk management Identify potential quality issues/discrepancies and resolve them in a compliant and timely manner Provide Clinical Quality support for vendor/CRO oversight, including updates on sponsor/CRO/site calls and critical quality issues Develop a risk-based audit program for internal processes, investigator sites, and vendors Establish clinical quality procedures and tools to support audit and compliance activities Collaborate on internal and external GCP audit plans Develop, implement, and maintain training and compliance programs, including GCP, GLP, and GVP training Partner with stakeholders on maintenance and implementation of other training across the organization to ensure full compliance Provide regulatory intelligence on changes to ICH and GCP regulations and assess impact on Invivyd systems Lead strategy and activities for health authority inspections (GCP, GLP, GVP) Review regulatory and nonclinical documents for consistency and compliance Communicate effectively in remote environments and manage multiple priorities with strong attention to detail Requirements
Bachelor’s degree in a scientific discipline or biotechnology Minimum 6 years of relevant GCP experience in pharma/biotech with quality systems in regulated GCP/ICH environments Experience leading and facilitating inspection readiness and hosting FDA/regulatory inspections Experience managing internal and external audits Strong understanding of GCP, FDA, and ICH regulatory standards/guidance Extensive knowledge of risk-based quality systems with a focus on ICH E6 R2 GCP principles Experience using Veeva Quality Vault Willingness to travel to clinical sites/vendors as required (up to 25%) Invivyd is an equal opportunity employer. We strive to create a welcoming and inclusive environment and provide equal employment opportunities without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected characteristics.
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Remote (Northeast Preferred) Overview
Invivyd is focused on delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2, with a proprietary platform to assess, monitor, develop, and adapt best-in-class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody in its pipeline. Join a team of innovators who are committed to making a difference and delivering life-saving solutions. Position summary
The primary responsibility of the Associate Director of Clinical Quality Assurance and Compliance is to develop and lead all quality assurance and compliance activities for the clinical development organization. The role is accountable for driving Clinical Quality initiatives to completion in collaboration with Regulatory and Clinical departments and external vendors. It also includes coordinating, controlling, and continuously improving internal QA processes related to clinical development and related activities and systems. The Associate Director will coordinate audits to support GCP, GLP, GVP, and other regulated activities and lead strategies for health authority inspections. The role ensures compliance of clinical trials and development activities with global regulatory standards (including US FDA, ICH, and other international regulators) and oversees clinical inspection readiness for Invivyd’s development programs. Responsibilities
Build the Clinical Quality Assurance and Compliance function and infrastructure to support Invivyd pipeline and related activities Participate on cross-functional team meetings as the Clinical Quality Assurance Subject Matter Expert (SME) Create, implement, and maintain efficient, phase-appropriate, and compliant GCP, GLP, and GVP systems and policies/procedures Partner with stakeholders to develop and maintain cross-functional SOPs, policies, procedures, and systems aligned with corporate objectives Support a risk-based approach to oversight of clinical trials using quality by design and quality risk management Identify potential quality issues/discrepancies and resolve them in a compliant and timely manner Provide Clinical Quality support for vendor/CRO oversight, including updates on sponsor/CRO/site calls and critical quality issues Develop a risk-based audit program for internal processes, investigator sites, and vendors Establish clinical quality procedures and tools to support audit and compliance activities Collaborate on internal and external GCP audit plans Develop, implement, and maintain training and compliance programs, including GCP, GLP, and GVP training Partner with stakeholders on maintenance and implementation of other training across the organization to ensure full compliance Provide regulatory intelligence on changes to ICH and GCP regulations and assess impact on Invivyd systems Lead strategy and activities for health authority inspections (GCP, GLP, GVP) Review regulatory and nonclinical documents for consistency and compliance Communicate effectively in remote environments and manage multiple priorities with strong attention to detail Requirements
Bachelor’s degree in a scientific discipline or biotechnology Minimum 6 years of relevant GCP experience in pharma/biotech with quality systems in regulated GCP/ICH environments Experience leading and facilitating inspection readiness and hosting FDA/regulatory inspections Experience managing internal and external audits Strong understanding of GCP, FDA, and ICH regulatory standards/guidance Extensive knowledge of risk-based quality systems with a focus on ICH E6 R2 GCP principles Experience using Veeva Quality Vault Willingness to travel to clinical sites/vendors as required (up to 25%) Invivyd is an equal opportunity employer. We strive to create a welcoming and inclusive environment and provide equal employment opportunities without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected characteristics.
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