Senior Director, Quality Control

Senior Director, Quality Control

Location: Greater Boston (Hybrid)

Overview

EPM Scientific is partnered with a clinical-stage biotechnology company developing innovative immunotherapy platforms to hire a Senior Director, Quality Control. Our client is seeking a hands-on QC leader to establish, build, and lead an internal GMP Quality Control laboratory while supporting the organization's continued clinical development and growth. This is a highly visible leadership opportunity for someone who enjoys building teams, developing laboratory infrastructure, and partnering cross-functionally in a fast-paced biotech environment.

Key Responsibilities

• Lead the establishment, operation, and continuous improvement of the internal GMP QC laboratory
• Provide leadership, mentorship, and development for QC laboratory personnel while building a strong quality and compliance culture
• Oversee daily QC laboratory operations, workflows, and execution standards
• Ensure laboratory activities are conducted in compliance with GMP requirements, internal procedures, and data integrity expectations
• Partner closely with Quality Assurance on investigations, deviations, CAPAs, change controls, and inspection readiness activities
• Collaborate with Analytical Development, R&D, Manufacturing, and Regulatory Affairs to support testing needs and program timelines
• Support internal and external audits, regulatory inspections, and QC-related quality system activities
• Implement scalable laboratory processes and systems to support organizational growth
• Drive continuous improvement initiatives while maintaining compliance and operational excellence
• Support hiring, onboarding, training, succession planning, and long-term QC capability development

Requirements

• Bachelor's degree in a scientific discipline; advanced degree preferred
• 10+ years of GMP Quality Control experience within biotech or pharmaceutical environments
• Prior leadership experience managing or developing QC laboratory teams
• Strong understanding of GMP QC operations, compliance, and inspection readiness
• Viral vector experience required; molecular biology background strongly preferred
• Ability to collaborate effectively across Quality, Manufacturing, R&D, and Technical Operations
• Comfortable working in a growing, fast-paced biotech environment
• Must be authorized to work in the U.S. without sponsorship