Head of Quality (GxP)

SummaryWe are partnering with a growing, science-driven biotechnology company to identify a Director of Quality for a pivotal leadership role at the intersection of strategy, development, and execution. This organization is advancing innovative, genetically informed approaches to developing precision medicines for patients with serious diseases and is entering an important stage of clinical maturity.This role offers the opportunity to shape and lead the Quality function during a critical phase of growth. The Director of Quality will be responsible for defining Quality strategy, building scalable systems, and ensuring GxP compliance across development programs as the company progresses into Phase 2 and beyond. A key emphasis will be on inspection readiness, robust vendor oversight, and the establishment of systems capable of supporting late-stage development and future commercialization.Reporting to the Vice President of Regulatory and Quality Science, this leader will manage and develop a small Quality team while fostering a culture of collaboration, accountability, and continuous improvement across the organization.Key Responsibilities and ImpactOwn and evolve the company's GxP Quality strategy, providing leadership across internal operations and external partners, including CROs, CMOs, CTLs, and other vendors supporting GxP activitiesDesign and implement risk-based, phase-appropriate Quality approaches for investigational materials, proactively identifying and mitigating Quality and compliance risks from early development through commercializationLead the development, implementation, and continuous improvement of Quality Systems, SOPs, and supporting infrastructure for all GxP activitiesProvide Quality oversight and strategic input into regulatory submissions and health authority interactions, including INDs, IMPDs, CTAs, and related correspondence with FDA and global regulatorsPartner closely with CMC and Operations, leading GMP vendor oversight to ensure manufacturing, testing, packaging, labeling, and distribution activities comply with cGMP, FDA, ICH, EMA, and applicable global standardsLead and oversee QA investigations, including product-impacting issues; review and approve deviations, complaints, recalls, audits, inspection findings, and associated CAPAs to ensure timely, effective resolutionDrive inspection readiness and serve as the primary Quality representative during regulatory inspections and auditsRepresent Quality on cross-functional teams and enterprise initiatives, providing clear, solution-oriented guidance to support informed decision-makingMonitor evolving global GxP regulations and industry best practices, proactively integrating regulatory intelligence into Quality systems and processesDevelop and deliver GxP training programs, embedding practical, compliant behaviors into day-to-day operations and promoting continuous improvementOversee Document Control systems, ensuring compliant lifecycle management, data integrity, and consistency across Quality recordsBuild team capability through effective delegation, coaching, and mentorship; encourage professional development, stretch goals, and inclusive leadership practicesCandidate ProfileBachelor's degree in a scientific discipline; advanced degree preferred12+ years of progressive experience in GxP Quality Assurance and compliance within biotech or pharmaceutical environmentsDeep understanding of global GxP regulations, including U.S. CFR, ICH, EMA, and related international standardsDemonstrated success building, scaling, and refining QA systems that support clinical development and commercial readinessStrong working knowledge of GMP Quality across raw materials, drug substance, drug product, labeling, packaging, testing, stability, and distributionExperience supporting the release of investigational and commercial materials in compliance with regulatory requirementsProven expertise in GxP training development and implementation, with an emphasis on effective adoption and sustainabilityTrack record of successfully supporting and leading regulatory inspections (FDA, EMA, and other global authorities)Hands-on experience drafting audit responses and driving effective CAPA implementationStrong root cause analysis, deviation management, and problem-solving skillsFamiliarity with electronic Quality Management Systems (eQMS) and eTMF platformsPrior experience managing and developing direct reports, with a focus on mentorship and team growthCollaborative and influential leadership style, with the ability to work effectively across functions and with external partnersStrong organizational, strategic, and communication skillsHigh ethical standards and a proactive, solution-oriented mindsetWillingness to travel domestically and internationally as needed for inspections, audits, and vendor oversight

Created: 2026-05-08