Associate Director, Clinical Quality Assurance and Compliance Invivyd, Inc. is seeking an Associate Director of Clinical Quality Assurance and Compliance to develop and lead all quality assurance and compliance activities for the clinical development organization. The primary responsibility of this role will be to drive Clinical Quality initiatives to completion in conjunction with Invivyd’s Regulatory and Clinical departments and external vendors. This position will also be responsible for coordinating, controlling, and continuously improving the internal quality assurance processes, primarily related to clinical development and related activities and systems. Responsibilities: Build the Clinical Quality Assurance and Compliance function and infrastructure to support Invivyd pipeline and other compliance-related activities Partner with other stakeholders across the organization to develop and maintain cross-functional SOPs, policies, procedures, and systems/activities consistent with corporate objectives Assist the Clinical Development organization in establishing procedures to support a risk-based approach to oversight of clinical trials using principles of quality by design and quality risk management Provide Clinical Quality Support for Clinical Vendor/CRO oversight Develop a risk-based audit program to conduct effective audits of internal processes, investigator sites, and vendors that support development activities Assist in the development, implementation, and maintenance of training and compliance programs Proactively provide key stakeholders with intelligence on changes and updates to ICH and GCP regulations and assess impact on Invivyd systems and practices Lead strategy and activities in support of GCP, GLP, and GVP health authority inspections Review regulatory clinical and nonclinical documents such as protocols, clinical study reports, IBs, ICFs, etc. and check for consistency and compliance with relevant regulations, standards, and best practices Competencies: Excellent written and oral communication and organizational skills Ability to work in a cross-functional team collaboratively and independently Ability to flexibly adapt to changing business needs and meet timelines Ability to proactively identify and determine impact of issues on subjects, study conduct, clinical program development, and company needs based on stage of development and risk profile Strong attention to detail and good problem-solving skills Requirements: A bachelor’s degree in a scientific discipline or biotechnology field A minimum of 6 years relevant GCP experience in pharma/biotech company, working within quality systems and regulated GCP/ICH environments Experience leading and facilitating inspection readiness activities and hosting FDA and other regulatory agency inspections Experience managing internal and external audits Strong understanding of GCPs, FDA, and ICH regulatory standards/guidance documents Extensive knowledge of risk-based quality systems approaches, with a focus on ICH E6 R2 GCP principles Experience using Veeva Quality Vault Invivyd is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a welcoming and inclusive environment for all employees.

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