Responsibilities

• Lead cGMP compliance activities for all relevant operations including activities related to manufacturing, testing and release of preclinical and clinical cell and gene therapy products
• Work closely with operation functions to enforce quality and regulatory requirements and provide quality oversight and leadership across these functions to assure compliance and strong relationships 
• Lead all quality aspects and deliverables of customers projects to ensure compliance and project progress
• Manage all quality related interactions with customers from IND enabling studies to routine clinical GMP operations
• Lead and host compliance audits including customer audits and health authorities/regulatory inspections
• Lead batch record review, lot disposition, material release, internal audit program, deviation handling, CAPA, change controls and quality events processes
• Lead the site Quality Management Review (QMR) and ensure the effectiveness of the Quality Management System
• Oversee and support new product introduction, tech transfer and process and analytical qualification activities
• Perform quality reviews and approval of all customers CMC/GMP documents needed for IND, BLA, CTA, etc.
• Oversee quality aspects of commissioning, qualification and validation activities for the facilities, utilities equipment and computer validation
• Review and approve Validation Master Plan, validation protocols and reports
• Lead and drive risk assessments and the implementation of the contamination control program
• Develop, author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed
• Actively manage a group of QA personnel and oversee their performance management, mentoring, and career development in line with their strengths
• Develop and manage departmental goals and corresponding budget in alignment with corporate vision and goals
• Recruit talent and builds a high performance team; mentors and coaches colleagues

Requirements

• Bachelor degree or higher in Life Sciences or related field
• 10+ years of relevant experience in the pharmaceutical or biopharmaceutical industries, including 7 years of leadership experience, and demonstrated knowledge of relevant cGMP regulations
• Experience with Cell and Gene Therapy products preferred
• Experience in client-focused development and manufacturing organizations preferred
• Demonstrated leadership with strong communication skills (both verbal and technical) and an ability to deliver results through teamwork
• Must be able to analyze processes, lead improvement activities, and empower staff to create a lean culture in the laboratory
• Demonstrated people management skills required
• In-depth knowledge of Good Manufacturing Practices (GMPs) 
• Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills
• In-depth knowledge of Quality principles, concepts, industry practices, and standards
• Keen understanding of international quality control systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives
• Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function
• Self-motivated and passionate about advancing the field of cell therapies
• Self-awareness, integrity, authenticity, and a growth mindset.