Vice President – Quality (Cell Therapy)

Job Responsibilities

• The Vice President of Quality will be responsible for entire life-cycle quality management including GMP, GLP & GCP
• You will manage all QA activities including both internal and external engagements
• Provide strategic guidance on product quality matters with responsibility for all deviations and investigations
• Implement and maintain a robust quality management system to meet regulatory standards
• As Vice President of Quality you will have oversight of GMP manufacturing processes and quality control testing
• Lead, mentor and develop a high performing quality team.
• Responsible for managing vendor-related quality initiatives, ensuring compliance and performance standards are met
• Ensure the accuracy and integrity of clinical and preclinical data overseeing QA for clinical Trials

Job Requirements

• Degree with at least 15+ years industry experience with a proven track record in leadership positions
• Comprehensive knowledge of GxP regulations and ICH guidelines
• Experience working with advanced therapeutics is essential, cell or gene therapy is highly preferred
• Proven track-record working with early-stage clinical development