Director / Senior Director / Executive Director, Quality Assurance

Location
New Jersey, United States, United States
Posted
Feb 20, 2021
Ref
2419632596
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Position Title: Director / Senior Director / Executive Director, Quality Assurance

Position Level: Director to Executive Director

Reports to: Chief Technology Officer

Department Name: Manufacturing

Location: NJ, GMP Manufacturing Facility

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:

The candidate will provide strategic and operational leadership in the areas of Quality Assurance and GMP Compliance for Century's new cell therapy GMP clinical manufacturing facility, for external development and manufacturing partners, and for cell line development efforts. Century's goal is to have a state-of-the-art multi-suite, multi-product cell therapy GMP facility in central New Jersey, capable of producing iPSC-derived immune cell therapies for Phase I/II clinical trials in the US, EU and Japan, with in-house QC, stability and microbiology capabilities. The candidate will develop and maintain site specific quality systems and will provide quality assurance and compliance oversight for the manufacture and release of cellular therapy clinical products at our internal and external sites.

Responsibilities will include, but are not limited to:
  • Lead all Quality Assurance and compliance activities related to manufacturing and releasing product for clinical trials at internal and external facilities, ensuring compliance with SOPs, GMPs and global regulations
  • Provide strategic and technical input to the development of manufacturing and assay controls consistent with the development strategies of our cellular products
  • Provide strategic and operational oversight to cell line development efforts, including cell procurement, iPSC reprogramming, gene editing, clone selection, pre-Master Cell Bank (MCB) activities, and all key raw material selection and qualification activities
  • Develop, implement, execute, and maintain site-specific quality systems for internal facilities including: Change Control, Corrective and Preventative Action, Vendor Qualification, Internal and External Audits, and Product Complaints
  • Provide compliance oversight and approval for SOP and validation development, process design, and risk management
  • Assume responsibility for record review and retention including: medical records, batch records, preventative maintenance, and validation records
  • Create policies and procedures/systems as they relate to Quality and the business
  • Establish and lead GMP training programs for clinical manufacturing, quality control and appropriate process/analytical development and research staff
  • Contribute quality and compliance components to regulatory submissions
  • Establish and maintain internal facilities in a state-of-inspection readiness for internal and regulatory audits. Serve as liaison for all audits and inspections
  • Estimate, report, and manage to a departmental budget
  • Present Quality Performance Indicators on a regular basis for management review


Qualifications:
  • BS or higher degree in an industry-related discipline
  • 12+ years of QA experience in developmental biopharmaceutical products with at least 5 years in a QA or GMP compliance operational role. Experience in cell therapy preferred but not required
  • Sound understanding of, and the ability to interpret, GMPs and regulatory guidance documents and ability to apply the principles to clinical GMP manufacturing and quality control areas
  • Advanced knowledge of current regulations governing GMP facility design and process/material/product/personnel flows


Requirements:
  • Possesses drive and passion with a proven track record of success
  • Ability to motivate and inspire operational teams
  • Excellent interpersonal skills with a team-first attitude
  • Good balance between strategic and logistical thinking
  • Strong technical problem-solving and decision-making skills
  • Excellent verbal and written communication skills


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