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
- Serve as the Quality lead for clinical trial activities, including vendor oversight and risk management
NDA Readiness & Regulatory Support
- 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
- Provide quality oversight of clinical data integrity and documentation supporting regulatory filings
Audit & Inspection Management
- Oversee internal and external GCP audits, including CROs, clinical sites, and vendors
- Lead preparation and management of regulatory inspections (e.g., FDA, EMA)
- Ensure timely and effective CAPA development and implementation
Quality Systems & Compliance
- Drive continuous improvement of quality systems, including SOPs, training, and documentation practices
- Ensure robust deviation, CAPA, and risk management processes are in place
- Promote a strong quality culture across the organization
Leadership & Cross-Functional Collaboration
- Build and lead a high-performing Quality team
- Act as a key advisor to senior leadership on GCP quality and regulatory risk
- Collaborate closely with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and CMC teams
Qualifications
- 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
- Excellent communication, strategic thinking, and problem-solving skills
Preferred Qualifications
- Experience in both early and late-stage clinical development
- Prior experience interacting directly with regulatory agencies
- Background in building or scaling quality systems in a growing organization
Work Environment
- Hybrid role based in Boston, MA
- 3 days onsite required with flexibility for remote work the remainder of the week
Why Join Us
- Opportunity to play a critical role in advancing innovative therapies
- High-impact position with visibility to executive leadership
- Collaborative and mission-driven culture
