Director, Quality Systems, Research & Development (R&D)
USFull-TimeDirector
Salary217,000 - 240,000 USD per year
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Job Details
- Experience
- 12+ years
- Required Skills
- Quality Assurance
Requirements
- 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.
Responsibilities
- 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.
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