Director of Quality

Responsibilities:

Reporting to the Vice President of Regulatory Affairs and Quality SystemsManage and provide vision and leadership to quality assurance and quality control for the cellular therapeutic group in a growing organizationQuality ControlOversee all testing performed by the QC department to includeExperience in clean room procedures and aseptic processingExperience in routine quality control testing (sterility, endotoxin, etc)Experience in PCR, flow cytometry and bioassaysOversee all raw material testing and release activitiesInteract with Process Development, Analytical Biology and Science organization to evaluate and integrate testing methodologies into QCDe novo, evaluate and integrate rapid analytical methods for cell therapy productsSupport and oversee all assay qualification and validation activitiesOversee consolidation of QC practices and procedures for harmonization of materials management between Massachusetts and Kentucky locationsInteract with and support Clinical Production for investigational biological productsConsulting support, as appropriate, to VPLQuality AssuranceOversee cGMP systems to include change control, vendor qualification, records management, equipment/process/computer validation, training and competency program and documentation, internal and external audits, SOPs, process improvement, change control and data review support for the Kentucky commercial operationsManage the Metrology and Facility Support programManage contracts and relationships with outside testing laboratories, contract manufacturers and other vendorsAdvocate and implement any necessary changes to keep ViaCell Therapeutics in compliance with applicable regulations and guidelinesDevelop, manage and communicate quality plans and goals for projects and ensure completionAct as primary liaison for the research and development team pertaining to quality matters generallyInterview and select new employees within the Quality Department and in the organization as appropriate Provide training as needed for staff and ViaCell employeesManage and mentor employees in all the above areas

Requirements:PhD (or Masters plus equivalent) experience in a Microbiology / Cell or Molecular Biology with 8 to 12 years of quality assurance and quality control experience in the biopharmaceutical industryDemonstrated ability to lead and influence others with 5 years experience in a direct managerial roleExperience in the development of validation procedures and maintenance of quality systems.Ability to think intuitively and problem solveExperience with GMP manufacturing for clinical trials.  GTP knowledge a plus.Ability to develop and maintain a strong quality teamExcellent communication across all organizational levelsAbility to objectively evaluate processes and proceduresAbility to successfully manage difficult/challenging situations with the potential to impact product qualityAbility to develop productive process evaluations and improvementsPublications experience a plus

Additional Information:

This position is located in Cambridge, MA and depending on hire date, will be expected to periodically travel to Worcester, MA in support of clinical trial production.  This position will make occasional (not more than 1 per quarter) trips to the commercial production facility in Kentucky.