Sigilon Therapeutics is a multidisciplinary biotechnology company which specializes in creating immune privileged products to address unmet clinical needs. Our mission at Sigilon Therapeutics is to create immune-protected, engineered human cells that restore normal physiology in a wide range of diseases without generating fibrosis or immune rejection, liberating patients from challenges associated with serious chronic diseases. We are based in Kendall Square in Cambridge, MA, and funded by Flagship Pioneering. Please send your application via email to email@example.com
Sigilon Therapeutics is searching for an energized candidate to develop our Quality systems at Sigilon. This person will have primary responsibility for developing and building out quality systems as we move toward an IND filing. Initial emphasis will be on developing a robust SOP template and system and working with staff to create appropriate SOPs. Responsibilities will expand as the organization matures. The person will be the internal expert in the principles and application of quality assurance and compliance. The Quality Manager will align systems and processes with corporate goals and compliance with all regulatory requirements.
• Responsible with providing quality oversight and support to Sigilon R&D
• Act as key compliance liaison with different functional departments.
• Provide support and guidance for quality and compliance for product release assay design and validation
• Responsible for conducting / leading compliance walk-throughs of the site
• Overall responsibility for being document owner for SOPs and group serves as reviewer / approver or owner of deviations to SOPs
• Responsible for serving as Trainer for quality systems where appropriate
• Understand and support business needs, provide quality guidance and facilitate resolution of quality issues in a timely manner. Provide quality recommendations to compliance issues and / or observations as they arise.
• Responsible for insuring quality at key CROs/CMOs