Senior Director Quality Assurance
hace 12 días
Boston
Job Title: Senior Director, Quality (GCP & NDA Focus) Location: Boston, MA (3 days onsite / 2 days remote) Position Overview We are seeking an experienced and strategic Senior Director of Quality to lead and oversee GCP quality systems and support NDA readiness and submissions. This role will be responsible for ensuring clinical quality compliance, inspection readiness, and alignment with global regulatory expectations across all GCP activities. The ideal candidate brings deep pharmaceutical/biotech experience and a strong track record of supporting successful regulatory filings, including NDAs. Key Responsibilities GCP Quality Leadership • Provide strategic leadership for GCP Quality Assurance across clinical development programs, • Oversee the development, implementation, and continuous improvement of GCP quality systems and processes, • Ensure compliance with global GCP regulations, ICH guidelines, and applicable health authority requirements, • Lead quality strategy and execution for NDA readiness, including gap assessments and remediation plans, • Partner cross-functionally with Regulatory Affairs, Clinical Development, and CMC to support submission activities, • Ensure inspection readiness for pre-approval inspections (PAIs) and health authority audits, • Oversee internal and external GCP audits, including CROs, clinical sites, and vendors, • Lead preparation and management of regulatory inspections (e.g., FDA, EMA), • Drive continuous improvement of quality systems, including SOPs, training, and documentation practices, • Ensure robust deviation, CAPA, and risk management processes are in place, • Build and lead a high-performing Quality team, • Act as a key advisor to senior leadership on GCP quality and regulatory risk, • Bachelor's degree in Life Sciences or related field (advanced degree preferred), • 15+ years of experience in Quality within the pharmaceutical or biotechnology industry, • Significant experience in GCP Quality Assurance and clinical trial oversight, • Demonstrated experience supporting NDA/BLA submissions and regulatory inspections, • Strong knowledge of global GCP regulations, ICH guidelines, and FDA/EMA expectations, • Proven leadership experience with the ability to influence cross-functional stakeholders, • Experience managing audits, inspections, and CAPA processes, • Experience in both early and late-stage clinical development, • Prior experience interacting directly with regulatory agencies, • Hybrid role based in Boston, MA, • Opportunity to play a critical role in advancing innovative therapies, • High-impact position with visibility to executive leadership, • Collaborative and mission-driven culture