Quality GxP Director

<p><strong>The role</strong></p> <p>Navigator Medicines is building an immunology-first biotech focused on bispecific drug discovery for immunology and inflammatory diseases. This Quality GxP Director role, reporting to the Vice President, Regulatory Affairs & Quality, is responsible for providing oversight by executing vendor qualification audits, ensuring compliance with GxP regulations, managing risks, monitoring compliance metrics, updating procedures, providing training and ensuring investigational products meet global standards and specifications. This role is ideal for a Quality GxP Director who thrives in a small, fast-moving biotech environment and wants broad ownership, close cross-functional collaboration, and meaningful impact on advancing clinical programs.</p> <p><strong>The problems you’ll work on</strong></p> <ul> <li>Contribute to the development, implementation, and maintain phase appropriate Quality Management Systems (QMS) to meet internal and external (ISO, FDA, etc.) standards.</li> <li>Designs and implements quality assurance training programs and education to key Navigator crew in conjunction with cross-functional managers.</li> <li>Management of internal and external audit programs.</li> <li>Reviewing and approving quality-related documentation, such as batch production records, to ensure completeness, accuracy, and compliance with internal procedures and regulations.</li> <li>Disposition of IMP for use in clinical trials</li> <li>Drive GxP quality issue compliance through identification and documentation of deviations, CAPAs, effectiveness checks, and change controls.</li> <li>Qualification, monitoring, and routine oversight of critical external service providers (CDMO, CROs, PV, CTLs etc.)</li> <li>Development of a phase appropriate risk management program</li> <li>Defining the long-term strategy for the quality organization while actively working on tactical, short-term strategies to support maturity of the quality management system</li> <li>Participate in selection and software validation activities for GxP systems.</li> </ul> <p><strong>What you’ll learn</strong></p> <ul> <li>How early-stage biotech companies build and execute clinical development programs from the ground up</li> <li>End-to-end exposure to regulatory submissions and health authority interactions</li> <li>How cross-functional teams collaborate to move programs efficiently through clinical milestones</li> <li>How to balance speed, rigor, and compliance in a growing clinical organization</li> </ul> <p><strong>How we work</strong></p> <ul> <li>Champions and cultivate a culture of quality within a diverse working environment.</li> <li>Brings unstoppable energy and enthusiasm to delivering top-quality results in a fast-paced, fun, and dynamic environment.</li> <li>How early-stage biotech companies build and execute clinical development programs from the ground up</li> <li>How cross-functional teams collaborate to move programs efficiently through clinical milestones</li> </ul> <p><strong>What You Bring</strong></p> <ul> <li>Strong working knowledge of quality management principles and experience with QMS tools and software</li> <li>Proven QA/QMS experience, including initial and routine qualification audits of CMOs/CROs to verify compliance with recognized standards and regulations</li> <li>Strong analytical, problem-solving, communication, and organizational skills</li> <li>Bachelor’s degree in life sciences or a related field</li> <li>5–7+ years of quality experience in biotech, pharma, or CDMO settings</li> <li>Strong understanding of clinical development processes and global regulatory requirements (ICH, GCP, FDA, EMA)</li> <li>Excellent writing, organizational, and collaboration skills</li> <li>Experience working in early-stage or small biotech environments preferred</li> </ul> <p>The salary range for this position is expected to be between $215,000 and $230,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.</p> <p><strong>About Navigator Medicines</strong></p> <p>Navigator Medicines is a clinical-stage biopharmaceutical company dedicated to advancing biologics for targeted immune regulation and restoration. Founded in 2024 as a subsidiary of Sera Medicines with $100M Series A financing co-led by RA Capital Management and Forbion, the company focuses on developing innovative therapies for complex autoimmune diseases. Navigator Medicines is committed to improving the lives of patients with heterogeneous conditions through cutting-edge science and groundbreaking advancements in immune therapeutics.</p> <p><strong>Legal & Equal Opportunity Notice</strong></p> <p>Navigator Medicines is an equal opportunity employer and provides reasonable accommodations as required by Massachusetts and California law.</p> <p> </p> <p> </p>