<p>Summary of Position:</p> <p>The Manager of Clinical Quality Assurance is responsible for planning, prioritizing, and conducting daily GCP quality assurance operations to support early to late-stage development. This role fosters impactful relationships, collaborations, and alignment within the Quality team, across the clinical development organization, and with CROs and other service providers, while advancing a risk-based quality and compliance program.</p> <p>The Manager of Clinical Quality Assurance assesses and collaborates with other key functional team members to continuously improve the quality systems and processes at Atea. They build fit-for-purpose quality into the clinical development processes while establishing plans and best practices that identify and manage potential risks to patient safety, product quality, and data integrity. This role manages and follows up on quality issues and audits specific to CROs, service providers, and investigative sites to ensure ongoing inspection readiness.</p> <p>Essential Duties and Responsibilities:</p> <p>Offer ongoing and strategic guidance and support on GCP quality-related matters to the clinical teams, collaborating actively to identify and mitigate risks.</p> <ul> <li>Actively engage in the preparation of Quality Agreements and other quality-related project plans, charters, and presentation materials. </li><li>Contribute to quality investigations by giving input on plans to resolve quality issues; oversee appropriate CAPAs related to deviations and investigations. </li><li>Review and provide feedback on the annual GxP service provider audit plan, clinical trial audit plans, and clinical trial risk assessments. </li><li>Assist in the overall management of an external audit team, which includes overseeing audit scheduling, conducting audits, and closing out for CROs, service providers, and investigative sites according to the audit schedule. </li><li>Offer feedback on the internal audit plan and carry out internal audits (e.g., internal Atea processes and systems) as necessary. </li><li>Collaborate with Quality Management and functional representatives to propose, initiate, and prepare SOPs and other necessary governance documents. </li><li>Implement the quality system to effectively manage GCP compliance activities, including document management, deviations, CAPAs, and effectiveness checks. </li><li>In collaboration with functional representatives and in alignment with Quality Management, ensure inspection readiness of internal clinical functions and systems, CROs, service providers, and investigative sites for inspections by global Regulatory Health Authorities. </li><li>Collaborate with key stakeholders to establish metrics, track, and report trends regarding the company's quality status and compliance with applicable regulations and industry standards. </li></ul> <p>Qualifications:</p> <ul> <li>A BS degree in a scientific field is required; an advanced degree in the sciences is a plus. </li><li>A minimum of 5 years of progressive responsibility in pharmaceutical and biotech GCP-related quality environments. </li><li>In-depth working knowledge of global GCP regulations and guidelines, including the implementation of ICH E6, ICH E8, 21 CFR 50, 21 CFR 312, and 21 CFR 11. </li><li>Hands-on experience in developing, managing, and closing out audit plans. </li><li>Direct experience in inspection readiness and late-stage clinical trials; experience in managing Health Authority inspections a plus. </li><li>Direct experience with electronic document/data management systems including eTMF and eDMS; experience with Veeva a plus. </li><li>Proven track record auditing and working with clinical CROs/service providers, and relationship management. </li><li>Effective written and oral communication skills. </li></ul> <p>Disclaimer:</p> <p>The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.</p>