Capital Associated Industries, Inc.
  • Raleigh, NC, USA
  • Full Time

The Director of U.S. GMP Quality Unit will serve as the senior advisor and responsible person on all quality issues, while building and leading a first-rate quality capability for Cellectis US manufacturing platform for investigational and commercial UCART products.

 

The Director of U.S. GMP Quality will be responsible for implementing quality assurance and quality control systems and processes for cell and gene therapy products being manufactured by Cellectis in the U.S. This position will also be responsible for all Quality Control responsibilities regarding testing and release of these products as well as being responsible for the quality levels of raw materials and components sourced from external manufacturers.

 

This role will function as a full partner with manufacturing and other technical operation groups, along with Corporate Quality and Regulatory representatives, working together to improve quality processes and manufacturing ability of products, and serving as "early warning radar" on quality related manufacturing problems.  

 

The Director of U.S. GMP Quality will be responsible for developing, maintaining and evolving quality systems, quality manuals, policies, procedures, protocols, operating methods and records to ensure product quality and compliance with cGMP regulations and applicable product approval as well as setting, monitoring and maintaining the Quality standards for the US manufacturing site for both investigational and commercial products. The position will be a key contributor for input into the Quality program for the Corporation.

The position will be based at the Cellectis' US manufacturing site but will require travel to the satellite office in Manhattan and the Corporate offices in Paris on occasion.

 

 

Central responsibilities include, but are not limited to:

  • Applying best practices with respect to aseptic biologic manufacturing.
  • Assess and provide recommendation to Company leadership management on Quality systems and equipment to be purchased and implemented.
  • Will serve as the key liaison on Quality matters with all functional departments, VP Global GMP Quality and the Chief Regulatory and Compliance Officer.
  • Overseeing all US GMP quality activities and ensure they are governed through key performance metrics and a quality review system.
  • Developing in conjunction with all relevant groups and following the review of quality systems, a Master Quality Plan for the manufacturing site.
  • Will have responsibility for articulating, leading and implementing the Master Quality Plan.
  • Will provide leadership on quality policies and practices while working in collaboration with multiple functions at Cellectis - including manufacturing, engineering, facilities, environmental health and safety, manufacturing support and technology and global compliance.
  • Will assure that finished products conform to government and company standards and regulatory approvals for clinical and commercial products.
  • Will be 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.
  • Will 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.
  • Will be responsible for establishing department budgets and managing expenditures appropriately.

 

Knowledge & Experience:

 

  • A strong, seasoned biopharmaceutical quality professional with a minimum of 15 years relevant experience.
  • Experience working with cell and gene therapy products a strong plus.
  • An advanced scientific degree is highly desirable.
  • A keen knowledge and experience base working with research and development and manufacturing groups on quality issues is essential.
  • A strong experience base on global GMP, QA and QC issues pertaining to biologics is required, expertise in aseptic manufacturing is required.
  • Knowledge of FDA, EU and International regulations, EU and US compendial requirements and industry best practices regarding documentation systems, design control, change control, product specifications and cGMP's.
  • Experience in managing budget.
  • Understanding of molecular biology would be a plus
  •  

 

Candidate Profile:

 

  • Strong leader who is able to achieve agreements through an educational collaborative approach and able to be firm and decisive on quality and compliance issues.        
  • Excellent communication, leadership, collaboration and interpersonal skills with an ability to serve as a mentor to junior staff.        
  • Experience on senior management team in either a global biopharmaceutical, or development stage entrepreneurial organizational is a plus.      
  • Experience in leading cross functional teams, working as a member of such teams, and providing functional resources under supervision to such teams.        
  • Ability to function in a result oriented, customer focused environment is essential.      
  • Ability to multi task teams is essential.        
  • Flexible and able to adapt to company growth and evolving responsibilities.  

 

Capital Associated Industries, Inc.
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

  • Sign Up For Job Alerts!

  • Share This Page
.