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Team: Product
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Quality Systems, Research & Development (R&D) based in the United States.
This is a high-impact leadership role responsible for shaping and advancing the Quality Management System (QMS) within a dynamic R&D environment transitioning toward late-stage development and regulatory licensure. The position plays a critical role in ensuring inspection readiness, regulatory compliance, and operational excellence across clinical and pre-commercial activities. You will drive the evolution of electronic quality systems, quality governance, and risk management frameworks aligned with global standards. Working cross-functionally, you will partner with technical, clinical, regulatory, and supply chain teams to ensure phase-appropriate quality integration. This role is central to supporting major regulatory milestones, including biologics license application readiness. It offers a strategic seat in building a strong, compliant, and scalable quality foundation in a mission-driven environment.
Accountabilities:
This role is responsible for leading and evolving enterprise quality systems to support late-stage development and regulatory readiness:
- Lead the design, implementation, and continuous improvement of the Quality Management System (QMS) to support clinical, licensure, and commercialization phases.
- Oversee eQMS processes including document control, training, deviations, CAPA, change control, supplier quality, and management review.
- Establish quality governance frameworks, KPIs, and reporting systems to ensure compliance, transparency, and continuous improvement.
- Drive quality risk management practices aligned with ICH Q9 principles across programs and operations.
- Lead inspection readiness activities and support regulatory inspections, audits, and health authority interactions.
- Manage supplier quality oversight, including CDMOs, CROs, laboratories, and critical vendors.
- Ensure data integrity and compliance with ALCOA+ principles across all GxP systems.
- Partner cross-functionally to embed quality into development, manufacturing, and regulatory processes.
- Bachelor’s degree required; advanced degree preferred in Life Sciences, Pharmacy, Chemistry, Engineering, or related field.
- 12+ years of progressive experience in Quality Assurance within biotech, vaccines, biologics, or pharmaceutical environments.
- Proven experience building and managing quality systems through late-stage development, validation, and commercialization readiness.
- Strong expertise in eQMS platforms, quality metrics, and governance systems.
- Experience overseeing external partners including CDMOs, CROs, and contract laboratories.
- Demonstrated success supporting regulatory inspections (FDA, BIMO, PAI; EMA/MHRA experience preferred).
- Strong knowledge of 21 CFR, ICH Q9, ICH Q10, and global GxP requirements.
- Experience with biologics/vaccine development, sterile manufacturing, and technology transfer.
- Proven leadership experience managing teams and driving organizational quality transformation.
- Strong communication, stakeholder influence, and cross-functional collaboration skills.
- Competitive annual salary range: $217,000 – $240,000 depending on experience and qualifications
- Comprehensive medical, dental, and vision insurance coverage
- Flexible spending accounts (FSA) options
- Flexible vacation policy, sick leave, and paid time off
- Short-term and long-term disability coverage
- 401(k) retirement plan with employer matching
- 10 federal holidays plus an end-of-year winter break
- Inclusive and equal opportunity work environment
- Opportunities for professional growth in a mission-driven, global health-focused organization.
Requirements:
This position requires deep expertise in pharmaceutical or biotech quality systems and strong leadership capability:
Benefits:
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