Senior Director, Quality Assurance
Position Overview
Our client is a clinical-stage biopharma company advancing a novel therapeutic platform for serious, unmet-need conditions. As the organization transitions from Phase II into Phase III development, they are seeking a Senior Director, Quality Assurance to play a foundational role in building and scaling a fit-for-purpose
Quality organization.
This is a high-impact opportunity for a Quality leader who is energized by building from the ground up. The ideal candidate will not bring a rigid “we’ve always done it this way” mindset but instead will partner with the organization to design Quality systems that are purpose-built, stage-appropriate, and scalable.
Key Responsibilities
Quality Strategy & System Build-Out
- Lead the design and implementation of a phase-appropriate Quality Management System (QMS) with a strong emphasis on GMP, while integrating GCP and broader GxP elements.
- Partner with existing external consultants to complete a GAP assessment and translate findings into a clear, actionable Quality roadmap.
- Own the rollout and adoption of a newly selected electronic QMS, ensuring it supports the organization rather than overburdens it.
- Build Quality frameworks that align with the company’s evolution from Phase II into Phase III development.
GMP-Focused Quality Leadership
- Provide QA oversight for drug substance and drug product manufacturing, including CDMO oversight, batch record review, deviations, investigations, change control, and CAPAs.
- Ensure GMP compliance across internal and external manufacturing activities in alignment with FDA, ICH, and global expectations.
- Support product disposition and release activities as appropriate for development stage.
GCP & Cross-Functional Quality Integration
- Establish Quality Oversight across Clinical Operations, Drug Safety, CMC, IT systems, and external vendors, ensuring consistent GxP alignment.
- Create and maintain a cross-functional Quality tracker spanning GCP, GMP, IT, CMC, Drug Safety, and Clinical activities to provide visibility into risks, gaps, and timelines.
- Partner closely with cross-functional leaders to embed Quality thinking early into decision-making and execution.
Inspection & Audit Readiness
- Serve as a primary Quality lead during regulatory inspections, partner audits, and vendor audits.
- Lead preparation activities, inspection responses, and CAPA development with clarity and accountability.
- Ensure inspection readiness is continuous rather than event-driven.
Quality Culture & Leadership
- Build a Quality culture rooted in empathy, education, and collaboration, not enforcement alone.
- Teach and reinforce a QA mindset across the organization, helping teams understand the intent behind Quality expectations.
- Act as a trusted advisor and partner rather than a gatekeeper.
Who You Are
- A builder who enjoys creating systems, processes, and structure from scratch.
- Comfortable operating in ambiguity and energized by an “everything is possible” mindset.
- Solution-driven — you identify issues and actively design paths forward.
- Empathetic, collaborative, and respected across functions.
- Confident engaging directly with regulatory agencies and external stakeholders.
Qualifications
Required
- 12+ years of Quality Assurance experience in biotech or biopharma.
- Strong GMP QA background, with working knowledge of GCP and broader GxP environments.
- Prior experience in small or emerging companies, ideally during periods of growth or transition.
- Experience leading or supporting GAP assessments and building Quality systems from early or mid-stage foundations.
- Direct experience supporting regulatory inspections and audits.
- Ability to work remotely while remaining highly engaged.
Preferred
- Experience supporting companies moving from Phase II to Phase III.
- Familiarity with modern electronic QMS platforms.
- Background in biologics, immunology, rare disease, or complex therapeutic platforms.