Senior Director Quality

This is a high-impact, hands-on leadership role for a quality leader who thrives in a lean, pre-commercial biotech environment and is ready to build scalable quality systems to support the company's path toward commercialization. The role reports to the VP, Technical Operations.

Responsibilities

• Quality Systems & Compliance:
  • Own and continuously improve the company's GxP Quality Management System (QMS), ensuring it is fit-for-purpose to support a commercial product launch.
  • Develop, implement, and maintain SOPs, policies, and quality procedures aligned with ICH, FDA, EMA, and GxP guidelines (GCP, GMP, GLP).
  • Lead internal quality audits, host regulatory agency inspections, and manage all associated audit responses and CAPAs.
  • Oversee deviation management, change control, risk assessment, and CAPA programs.
  • Ensure compliance with applicable regulations including 21 CFR Parts 210, 211, 312, and applicable ICH guidelines.
  • Drive phase-appropriate quality risk management strategies across all programs and operations.
  • Serve as primary quality representative in regulatory body interactions with FDA, EMA, and other agencies as needed.
  • Partner with Regulatory to support IND/NDA/BLA filings and CMC sections.
  • Maintain the Annual Product Review (APR) / Product Quality Review (PQR) process.
• Manufacturing Quality (CMC & Commercial Readiness):
  • Provide end-to-end quality oversight of externally executed GxP activities, including drug substance (DS) and drug product (DP) and packaging manufacturing activities to support both clinical and commercial production.
  • Manage Quality Agreements with all external manufacturing and testing partners; lead vendor qualification and quality monitoring to ensure partners meet contractual and regulatory quality obligations.
  • Provide decision authority on final batch disposition and oversee review and approval of batch records, specifications, test methods, and validation protocols/reports.
  • Oversee stability programs, raw material qualification, and supplier quality management.
  • Support CMC development activities, including process characterization, scale-up, and technology transfer.
  • Provide quality support for Phase I, II, and III clinical trial material (CTM) manufacturing and release.
  • Provide quality support for commercial validation and launch activities, including support for NDA preparation and PAI readiness at CMOs and internally.
  • Build and lead commercial-scale quality readiness activities, including commercial GMP infrastructure planning.
• Leadership & Cross-Functional Partnership:
  • Serve as a key member of the Technical Operations leadership team; partner with VP, Technical Operations on quality strategy, resource planning, and organizational priorities.
  • Develop a 3–5 year Quality Plan in alignment with the overall organizational goals, including support for commercial launch.
  • Collaborate with Manufacturing, Clinical Operations, Regulatory, Supply Chain, and Program Management to ensure quality is embedded throughout all product development and manufacturing activities.
  • Recruit, mentor, and develop quality staff as the organization scales toward commercialization.
  • Effectively manage quality-related budgets, timelines, and vendor/CMO relationships.
  • Represent quality in cross-functional governance meetings, project teams, and executive/investor discussions as needed.
  • Communicate quality metrics, KPIs, and risk assessment to senior leadership.

Requirements

• Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, Biochemistry, or related field); advanced degree (MS, PhD, PharmD) strongly preferred.
• Minimum of 12–15 years of progressive pharmaceutical/biotech quality experience, with at least 5 years in a senior leadership capacity.
• Deep expertise in both Quality Systems/Compliance and Manufacturing Quality (CMC); experience spanning small molecules and/or biologics.
• Demonstrated experience supporting clinical-stage programs (Phase I, II, and/or III) through regulatory submissions (INDs, CTAs, NDAs/BLAs/MAAs).
• Hands-on experience managing CMOs/CDMOs in a quality oversight capacity.
• Strong working knowledge of FDA GMP regulations (21 CFR Parts 210/211) and ICH guidelines (Q7, Q8, Q9, Q10, Q11).
• Experience managing regulatory inspections (FDA, EMA, or equivalent) and leading successful inspection outcomes.
• Proven ability to build and scale quality systems in a lean, resource-constrained environment.
• Excellent communication skills with the ability to translate complex quality and compliance topics for non-technical stakeholders, including executives and Board members.
• Ability to work in a fast-paced, small company environment with multiple competing responsibilities.
• Position involves 10–20% travel.

Preferred Qualifications

• Experience in both pre-commercial and commercial manufacturing quality environments.
• Exposure to biologics, gene therapy, or cell therapy manufacturing quality.
• Prior experience building a quality organization from the ground up.