Summary
We are partnering with a growing, science‑driven biotechnology company to identify a Director of Quality for a pivotal leadership role at the intersection of strategy, development, and execution. This organization is advancing innovative, genetically informed approaches to developing precision medicines for patients with serious diseases and is entering an important stage of clinical maturity.
This role offers the opportunity to shape and lead the Quality function during a critical phase of growth. The Director of Quality will be responsible for defining Quality strategy, building scalable systems, and ensuring GxP compliance across development programs as the company progresses into Phase 2 and beyond. A key emphasis will be on inspection readiness, robust vendor oversight, and the establishment of systems capable of supporting late‑stage development and future commercialization.
Reporting to the Vice President of Regulatory and Quality Science, this leader will manage and develop a small Quality team while fostering a culture of collaboration, accountability, and continuous improvement across the organization.
Key Responsibilities and Impact
- Own and evolve the company’s GxP Quality strategy, providing leadership across internal operations and external partners, including CROs, CMOs, CTLs, and other vendors supporting GxP activities
- Design and implement risk‑based, phase‑appropriate Quality approaches for investigational materials, proactively identifying and mitigating Quality and compliance risks from early development through commercialization
- Lead the development, implementation, and continuous improvement of Quality Systems, SOPs, and supporting infrastructure for all GxP activities
- Provide Quality oversight and strategic input into regulatory submissions and health authority interactions, including INDs, IMPDs, CTAs, and related correspondence with FDA and global regulators
- Partner closely with CMC and Operations, leading GMP vendor oversight to ensure manufacturing, testing, packaging, labeling, and distribution activities comply with cGMP, FDA, ICH, EMA, and applicable global standards
- Lead and oversee QA investigations, including product‑impacting issues; review and approve deviations, complaints, recalls, audits, inspection findings, and associated CAPAs to ensure timely, effective resolution
- Drive inspection readiness and serve as the primary Quality representative during regulatory inspections and audits
- Represent Quality on cross‑functional teams and enterprise initiatives, providing clear, solution‑oriented guidance to support informed decision‑making
- Monitor evolving global GxP regulations and industry best practices, proactively integrating regulatory intelligence into Quality systems and processes
- Develop and deliver GxP training programs, embedding practical, compliant behaviors into day‑to‑day operations and promoting continuous improvement
- Oversee Document Control systems, ensuring compliant lifecycle management, data integrity, and consistency across Quality records
- Build team capability through effective delegation, coaching, and mentorship; encourage professional development, stretch goals, and inclusive leadership practices
Candidate Profile
- Bachelor’s degree in a scientific discipline; advanced degree preferred
- 12+ years of progressive experience in GxP Quality Assurance and compliance within biotech or pharmaceutical environments
- Deep understanding of global GxP regulations, including U.S. CFR, ICH, EMA, and related international standards
- Demonstrated success building, scaling, and refining QA systems that support clinical development and commercial readiness
- Strong working knowledge of GMP Quality across raw materials, drug substance, drug product, labeling, packaging, testing, stability, and distribution
- Experience supporting the release of investigational and commercial materials in compliance with regulatory requirements
- Proven expertise in GxP training development and implementation, with an emphasis on effective adoption and sustainability
- Track record of successfully supporting and leading regulatory inspections (FDA, EMA, and other global authorities)
- Hands‑on experience drafting audit responses and driving effective CAPA implementation
- Strong root cause analysis, deviation management, and problem‑solving skills
- Familiarity with electronic Quality Management Systems (eQMS) and eTMF platforms
- Prior experience managing and developing direct reports, with a focus on mentorship and team growth
- Collaborative and influential leadership style, with the ability to work effectively across functions and with external partners
- Strong organizational, strategic, and communication skills
- High ethical standards and a proactive, solution‑oriented mindset
- Willingness to travel domestically and internationally as needed for inspections, audits, and vendor oversight
