Director, Clinical Quality Assurance - Raleigh - Cellectis

    Cellectis
    Cellectis Raleigh

    5 days ago

    Description
    Job Description
    The Director, Clinical Quality Assurance is primarily responsible for establishing and leading the Clinical QA function and providing independent oversight of Good Clinical Practices (GCP) activities to ensure compliance with FDA, EMA, ICH, and other applicable global and national regulatory requirements across Cellectis' clinical programs. This role provides strategic and operational quality leadership in alignment with other departments and company goals. They develop and implement a comprehensive Clinical Quality Assurance framework that safeguards patient safety, data integrity, and regulatory compliance throughout the clinical development lifecycle. The Director, Clinical Quality Assurance, will manage activities and projects based on short-term and long-term company goals. This position is also part of the Global Cellectis Quality Leadership team actively contributing to the overall global Quality strategy and initiatives.
    Position Responsibilities
    • Defines and executes the Clinical QA strategy throughout the development trajectory including early-phase and late stage clinical development
    • Oversees GCP compliance for all clinical activities, including monitoring, data management, and pharmacovigilance
    • Develop and implement inspection readiness plans and procedures ensuring that clinical studies and related activities are ready for Health Authority inspections
    • Direct risk-based quality planning and continuous improvement initiatives across clinical programs
    • Manage vendor qualifications, audits, and corrective/preventive actions (CAPAs)
    • Collaborate cross-functionally to integrate quality principles into clinical development and regulatory deliverables
    • Provide training and guidance to cross-functional teams on GCP regulations, Quality Assurance procedures, and audit protocols
    • Develops quality strategies and priorities for short- and long-term objectives for the QA organization.
    • In collaboration with internal stakeholders, ensure risk-based quality management is applied as appropriate to specific studies
    • Facilitate review of potential Serious Breach and Urgent Safety Measure assessments arising from clinical program
    • Plan, coordinate, review, and approve clinical audits using risk-informed strategy to ensure compliance in clinical studies and pharmacovigilance operations
    • Implement and run internal GCP audit and training programs
    • Serve as a subject matter expert on GCP quality assurance matters
    • Develop KPIs to track and trend key Quality Indicators and ensures that any adverse trends or patterns are noted and are promptly addressed
    • Travel up to 10% of the time
    • Such other responsibilities and duties as the Company may from time-to-time assign
    Education and Experience
    • Bachelor's or master's degree in science preferably in a Life Science, with at least twelve (12) years of relevant GCP, PV, and QA experience in a biopharmaceutical company. 8+ years of direct supervisory experience.
    • Extensive clinical trial experience in biological therapies and in oncology, ideally in CAR-T therapies and hemato-oncology.
    • Experience supporting IND, CTA, and BLA/MAA or other regulatory submissions.
    Technical Skills / Core Competencies
    • Demonstrated ability to identify critical program risks and develop plans, strategic or tactical, to mitigate risks and costs. Knowledge and understanding of regulations regarding cell/gene therapies including but not limited to ICH guideline, GCP, and GMP as defined by the US Food and Drug Administration and European Medicines Agency.
    • Comprehensive knowledge of cell and gene therapy, GxPs, and the theories and general principles behind them.
    • Comprehensive knowledge of compliance with GCP worldwide regulations. Strong project management skills.
    • Demonstrated ability to lead, motivate, and influence a strategic direction. Ability to effectively leverage and develop diverse perspectives and ideas from matrix teams.
    • Ability to independently lead initiatives, assess complex challenges, and implement practical solutions.
    • Strong written and verbal communication skills. Bilingual in French and English preferred.
    • Ability to set and manage priorities and schedule activities accordingly. Strong analytical and problem-solving skills.
    • Demonstrated interpersonal skills to work effectively with subordinates, peers, managers, and cross-functional teams.
    • Excellent organizational skills with attention to detail and deadlines.
    • Strong team orientation including the ability to coach and mentor.
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