Manager/Senior Manager Supplier Quality

Location
Branchburg, NJ, United States
Posted
Jul 21, 2021
Ref
2648282416
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Position Title: Manager/Senior Manager Supplier Quality

Position Level: Manager

Reports to: Senior Director Quality Assurance

Reports to: Danielle Menniti

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:

Reporting to the Senior Director, Quality Assurance, the QA Manager Supplier Quality will be responsible for establishing and overseeing Century's Supplier Management program. This role will be based out of our GMP facility in Branchburg NJ.

This position will be responsible for the Quality oversight of all material suppliers supporting Century's product pipeline. The QA Manager of Supplier Quality will be a crucial leader as they will be responsible for developing the supplier quality program, establishing supplier qualification requirements, and developing and sustaining a partnership with suppliers on behalf of Century Therapeutics. In addition, this role will partner with Century's Supply Chain function to establish the materials management program, establish the material release program for Century's manufacturing facilities, and assist in the development and implementation of the enterprise resource planning/ inventory management systems.

Responsibilities:
  • Serve as the primary Quality interface between Century Therapeutics and their material suppliers.
  • Develop the Material Supplier Qualification Program and conduct supplier evaluation, selection, and qualification.
  • Author, review and execute supplier Quality Agreements.
  • Support supplier audits and due diligence assessments, as required.
  • Monitor, track and report on supplier performance and work with suppliers on quality issues.
  • Build and maintain effective cross-functional relationships with suppliers and internal Century departments.
  • Serve as a Quality subject matter expert on material suppliers.
  • Implement and own Century's Global Material QA release program, including material specifications.
  • Partner with Supply Chain leadership to develop and implement a new inventory management system.
  • Lead projects with cross-functional and/or Global scope.
  • Communicate confidently and effectively with management, peers, and key stakeholders.
  • Create and review risk management documentation to reduce or eliminate risk associated with the supplier and materials management program.
  • Provide Quality Assurance technical review and approval of documentation, protocols, reports, policies.


Qualifications:
  • BS or MS degree in a relevant biological, technical, or engineering field and 10+ years of relevant professional experience.
  • 8+ years of relevant cell/gene therapy or biologics manufacturing experience, with at least 5 years in Quality Assurance and/or Compliance


Requirements:
  • Strong knowledge of cGMP/Biopharmaceutical regulations
  • Hands-on experience with QA oversight of material suppliers or contract manufacturing organizations is highly desired, but applicable Quality Assurance experience will be considered.
  • Cell therapy experience preferred; experience with gene therapy, biologics, or vaccine development will be considered.
  • Knowledge of applicable regulatory compliance requirements.
  • Track record of developing processes and SOPs.
  • Proven ability to work effectively in a fast-paced and hands-on environment, and to communicate effectively.


Location:

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

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