Stratacuity: Proven Scientific Placement
Sr. Director, R&D Quality and Compliance
Stratacuity: Proven Scientific Placement, Cambridge, Massachusetts, us, 02140
Sr. Director, R&D Quality and Compliance
Sr. Director, R&D Quality and Compliance Location:
Hybrid Onsite (Cambridge, MA) Focus:
GxP Quality Oversight for Cell & Gene Therapy Overview Seeking a strategic leader to oversee global R&D Quality Assurance across clinical, research, and pharmacovigilance programs. This role ensures compliance with GCP, GLP, GVP, and research standards, drives inspection readiness, and fosters a culture of quality across internal teams and external partners. Key Responsibilities Lead R&D QA strategy and implementation for global clinical trials and research programs Oversee quality systems, audit programs, and inspection readiness (FDA, EMA, MHRA) Partner cross-functionally to assess risks, resolve quality issues, and ensure regulatory compliance Guide development of audit plans, CAPAs, and quality risk management strategies Manage and mentor QA team; contribute to organizational strategy and culture Interface with CROs, vendors, and regulatory bodies to ensure alignment and excellence Qualifications M.S. and 15+ years (or B.S. and 17+ years) in GLP/GCP/GVP quality and compliance 10+ years in leadership roles with proven success in inspections and regulatory strategy Deep knowledge of global GCP regulations and quality systems for cell/gene therapies Strong communication, strategic planning, and cross-functional leadership skills Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
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Sr. Director, R&D Quality and Compliance Location:
Hybrid Onsite (Cambridge, MA) Focus:
GxP Quality Oversight for Cell & Gene Therapy Overview Seeking a strategic leader to oversee global R&D Quality Assurance across clinical, research, and pharmacovigilance programs. This role ensures compliance with GCP, GLP, GVP, and research standards, drives inspection readiness, and fosters a culture of quality across internal teams and external partners. Key Responsibilities Lead R&D QA strategy and implementation for global clinical trials and research programs Oversee quality systems, audit programs, and inspection readiness (FDA, EMA, MHRA) Partner cross-functionally to assess risks, resolve quality issues, and ensure regulatory compliance Guide development of audit plans, CAPAs, and quality risk management strategies Manage and mentor QA team; contribute to organizational strategy and culture Interface with CROs, vendors, and regulatory bodies to ensure alignment and excellence Qualifications M.S. and 15+ years (or B.S. and 17+ years) in GLP/GCP/GVP quality and compliance 10+ years in leadership roles with proven success in inspections and regulatory strategy Deep knowledge of global GCP regulations and quality systems for cell/gene therapies Strong communication, strategic planning, and cross-functional leadership skills Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
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