Vice President, Global Quality

Cellectis Raleigh, NC , Wake County, NC

Posted 2 days ago

Position Responsibilities Responsible for implementing quality systems and processes for the GMP manufacturing facilities in Paris and Raleigh Responsible for all Quality Control regarding testing and release of manufactured products at the company’s two manufacturing facilities materials, raw materials and components purchased from external manufacturers Responsible for ensuring the quality levels of raw materials and components purchased from external manufacturers and suppliers Developing quality policies, programs and processes required for the Paris and Raleigh Manufacturing Sites and ensuring the implementation and direction of those programs is in compliance with good manufacturing processes (GMP) Enhance and evolve quality systems, policies, and procedures to ensure product quality and compliance with cGMP regulations and set the Quality standards for the manufacturing sites Serve as the key liaison on Quality matters with all functional departments Oversee all quality activities to ensure that they are harmonized and governed through key performance metrics and a quality review system Provide leadership on quality policies and practices while working in collaboration with multiple functions at Cellectis - including manufacturing, engineering, facilities, environmental health and safety, and Manufacturing Support and Technology Ensure that finished products conform to government and company standards for clinical and commercial products Responsible for championing a partnership/customer focus approach in the organization so that all functions view the quality organization as a proactive collaborator and partner to facilitate achieving goals Provide the leadership to assure the preparation of appropriate documentation for filing with regulatory bodies Provide the overall leadership in respect to recruiting, training, developing and supervising staff to accomplish quality compliance and goals Responsible for establishing department budgets and managing expenditures appropriately. Such other responsibilities and duties as the Company may from time to time assign Education and Experience Bachelors Degree in scientific area Minimum of 10 years of related, industry experience Experience in both commercial and clinical manufacturing quality Experience on senior management team in either a global bio-pharmaceutical, or development stage entrepreneurial organization.

Experience in leading cross functional teams, working as a member of such teams, and providing functional resources under supervision to such teams. Technical Skills / Core Competencies Excellent communication, leadership and interpersonal skills with an ability to serve as a mentor to junior staff. Strong leader who can achieve agreements through an educational collaborative approach and able to be firm and decisive on quality and compliance issues.

Ability to function in a results oriented, customer focused environment is essential. Ability to multitask teams is essential. Flexible and able to adapt to company growth and evolving responsibilities.


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Vice President, Global Quality

Cellectis