Associate Director/Director QA Operations and Engineering

Company Background:

Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of current cell therapies. Century's genetically engineered, universal iPSC-derived immune effector cell products are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care.

Century's foundational technology is built on induced pluripotent stem cells (iPSCs) that have unlimited self-renewing capacity. This enables complex cellular engineering to produce controlled cell banks of modified cells that can be expanded and differentiated into desired immune effector cells, which can supply vast amounts of allogeneic, homogeneous therapeutic products. This platform differentiates Century from other approaches that utilize non-renewable donor-derived cells.

Role:

Century Therapeutics is seeking a Director QA Operations at the Century Cell Therapy Manufacturing Facility in Branchburg, NJ reporting to the Senior Director Quality Assurance. This role will be responsible for leading the day-to-day Quality Assurance operations at the Branchburg, New Jersey Cell Therapy site including but not limited to drug product and materials disposition, batch record review, Quality oversight of site engineering and validation activities, quality “on-the-floor” support to manufacturing operations and review and approval of site-specific procedures, deviations and GMP documentation. This role will also support batch review and lot disposition activities for Century products manufactured by Contract Manufacturing Organizations (CMOs). This individual will be a key leader on the management team and a champion for quality principles and compliance within the Quality Assurance organization.

Responsibilities:

• Responsible for Quality Assurance oversight of GMP operations at the Branchburg NJ cell therapy manufacturing facility and ensuring adherence to applicable GMP regulations and Century Therapeutics policies and procedures
• Assure product quality and compliance by implementing and enforcing quality assurance policies and procedures; ensures the required processes, procedures, systems and resources are in place to enable a compliant disposition of all materials and cell therapy products
• Manage batch review and lot disposition activities and communicate lot disposition status; participate in Material Review Board meetings and evaluate recommendations made by the board during product disposition
• Implement an effective “QA on-the-floor” program
• Provide Quality oversight of all Branchburg site engineering and validation activities, including facility start up, shut down, aseptic process simulations and equipment qualification and maintenance
• Ensure timely QA support to the site manufacturing operations and compliance activities, including but not limited to approval of GMP documentation, risk assessments, change control impact assessments, root cause analysis during deviation investigations, and development of corresponding CAPAs
• Manage and host regulatory inspections and corporate audits. Conduct internal housekeeping audits
• Develop and manage the quality hold and product recall processes for Century
• Provide leadership and build an exceptional team to manage the Quality Assurance functions, including hiring, mentoring, and developing personnel
• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management system
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Branchburg facility
• Develop departmental goals and ensure timely completion of all deliverables
• Champion and foster a positive and quality compliance culture

Qualifications:

• BS or MS degree in a relevant biological, technical, or engineering field and 10+ years of relevant professional experience.
• 10+ years of relevant cell/gene therapy or biologics manufacturing experience, with at least 8 years in Quality Assurance and/or Compliance

Requirements:

• Expertise in GMP compliance and global regulations
• Experience with implementing and overseeing GMP operations in a clinical and/or commercial manufacturing facility is required
• Demonstrated Quality leadership through a partnership approach with Manufacturing Operations to enable high quality and compliant product distribution to patients is required
• Track record of building and leading exceptional Quality Assurance teams is required
• Experience in continuous improvement, operational excellence and six-sigma is desired
• Excellent written and verbal communication required with the ability to work cross-functionally and to develop and maintain strong business partner relationships
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment

Location:

This role will be located in Branchburg, NJ and requires the ability to travel domestically up to 25%