Responsibilities

• Oversee the clinical cGMP operations and ensure adherence to applicable regulations, policies/standards, and Customer requirements
• 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 cGMP compliance activities for all relevant operations including activities related to manufacturing, testing and release of pre clinical and clinical cell and gene therapy products
• Provide quality guidance ensuring phase appropriate approach to product development projects and technical transfer activities
• Lead batch record review and lot disposition, material release, deviation handling, quality events processes
• Support regulatory CMC activities
• Oversee and support new product introduction, tech transfer and process and analytical qualification activities
• Oversee quality aspects of commissioning, qualification and validation activities for the facilities, utilities and equipment
• Review and approve Validation Master Plan, validation protocols and reports
• Lead and drive risk assessments and the implementation of the contamination control program
• Manage the GMP Quality Operations group, ensuring that Quality Operations  processes provide high quality support for manufacturing, QC maintenance, engineering, and validation operations while ensuring compliance with protocols, GMP’s, and safety regulations
• Responsibility to 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. 
• Works with Quality and Regulatory standards to ensure requirements are met and property documented. 
• Will work on more complex problems where analysis of situations or data requires in-depth evaluation of various factors, strong judgment is required in resolving problems and making recommendations - typically high impact issues that have implications across functions
• Supports internal and external regulatory audits as required
• 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

• Master degree (preferably in Life Science) or equivalent work experience, and a minimum of 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
• 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.