<p><strong>Vice President, Quality Assurance</strong></p> <p>City Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients with serious unmet medical needs. As we progress our pipeline through critical regulatory and clinical milestones, we are seeking a seasoned VP of Quality Assurance to lead and own our quality assurance strategy and systems across the organization.</p> <p>The Vice President, Quality Assurance will be the senior quality leader at City Therapeutics, responsible for the design, implementation, and continuous improvement of the company's Quality Management System (QMS) and all quality assurance functions. This individual will ensure that all development, manufacturing, and clinical activities are conducted in full compliance with cGXP regulations, applicable regulatory guidance, and internal standards. As a key member of the leadership team, the VP of QA will embed a culture of quality across the organization and ensure the company is perpetually inspection-ready.</p> <p><strong>Key Responsibilities:</strong></p> <p><strong>Quality Strategy & Leadership</strong></p> <ul> <li>Define and lead the enterprise-wide Quality Assurance strategy, ensuring alignment with regulatory requirements, industry best practices and business objectives.</li> <li>Lead quality risk management activities, identifying potential risks and implementing mitigation strategies proactively</li> <li>Build, develop, and retain a high-performing QA team, establishing clear roles, accountability structures, and career development pathways</li> <li>Champion and embed a proactive quality culture across all departments, serving as the organizational authority on quality matters</li> <li>Establish and monitor quality KPIs, metrics, and dashboards; report quality status and trends to executive leadership and the Board as appropriate</li> </ul> <p> </p> <p><strong>cGXP Compliance</strong></p> <ul> <li>Provide executive oversight of all cGXP activities, ensuring compliance with FDA, EMA, ICH, and other applicable international regulations (21 CFR Parts 210/211/312/600, ICH Q7, Q9, Q10, E6, and related guidelines)</li> <li>Own and continuously improve the Quality Management System, including SOPs, change control, deviation and CAPA management, document control, and training programs</li> </ul> <p> </p> <p><strong>Regulatory Inspections & Agency Interactions</strong></p> <ul> <li>Drive and maintain a state of continuous inspection readiness across all sites and functions</li> <li>Collaborate with Regulatory Affairs to prepare and review quality sections of IND, BLA, NDA, and other regulatory submissions</li> <li>Serve as the primary QA lead during FDA, EMA, and other regulatory agency inspections and audits; manage all aspects of inspection response and commitments</li> </ul> <p> </p> <p><strong>Supplier, CMO & CRO Oversight</strong></p> <ul> <li>Establish and maintain a robust vendor qualification and audit program for all CDMOs, CMOs, CROs, and critical suppliers</li> <li>Negotiate, review, and execute Quality Technical Agreements with all external partners</li> </ul> <p> </p> <p><strong>Cross-Functional Partnership</strong></p> <ul> <li>Partner with Clinical Operations, Regulatory Affairs, CMC, R&D, and Supply Chain to integrate quality requirements into every stage of the product lifecycle</li> <li>Support due diligence activities and integration planning for partnerships, in-licensing, and M&A transactions as needed</li> </ul> <p> </p> <p><strong>Qualifications:</strong></p> <ul> <li>Bachelor's degree in life sciences, pharmacy, chemistry, or a related field; advanced degree (MS, PhD, PharmD) strongly preferred</li> <li>15+ years of progressive Quality Assurance experience in the biopharmaceutical or pharmaceutical industry, with a minimum of 5 years in a senior or executive leadership role</li> <li>Demonstrated experience building and scaling QA functions in a clinical-stage or growth-phase biopharmaceutical company</li> <li>Working knowledge of international regulatory frameworks including EMA, ICH, and PMDA requirements</li> <li>Strong leadership presence with the ability to influence cross-functionally, communicate effectively at the executive level, and drive organizational alignment</li> <li>Proven track record leading successful regulatory inspections (FDA, EMA, or equivalent) and managing health authority interactions and responses</li> <li>Extensive experience managing CMO, CDMO, and CRO quality relationships and overseeing multi-site QA systems</li> <li>Comprehensive, hands-on expertise in GMP and GCP regulations, including FDA 21 CFR Parts 210/211/312/600 and ICH Q7, Q9, Q10, and E6(R2)</li> </ul> <p> </p> <p><strong>Preferred</strong></p> <ul> <li>Experience across multiple modalities including biologics, and/or cell and gene therapies</li> <li>Prior experience supporting a product through BLA/NDA approval and commercial launch</li> </ul> <p><strong>Our Working Model: In Person, By Design</strong></p> <p>At City, we believe that science and culture thrive together, and that happens best in person. Our working model is clear: we work onsite at our Kendall Square offices five days per w