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Job Title: Quality Manager, Gene Therapy
The Quality Manager will primarily manage the assigned programs focused on Gene Therapy modalities and possess a strong knowledge of cell-based production for drug development and transition to commercialization. This role is recognized to be knowledgeable in the principles and application of quality and regulatory compliance with significant knowledge of regulations applicable to Gene Therapy. The Quality Contractor adapts to new project requirements, business partnerships, effectively ensuring alignment with corporate goals and compliance with applicable regulations.This role is responsible for product disposition of clinical products which includes drug substance, drug product intermediate, and drug product. The Quality Contractor assists with the implementation of Quality System at contract manufacturers.
Provide strategic GMP quality/compliance guidance to internal stakeholders as GMP QA trusted advisor on pharmaceutical development/CMC teams.
oCollaborative reviewer of procedures with external business partners and vendors
oUnderstandingproject plans, timelines and regulatory filing strategy and communicate them to Quality management in a timely manner
Disposition of externally produced materials and products in support of Clinical Studies which includes but not limited to
oQA review of Executed Batch Records and resolution of comments/issues
oIn-Process and Final product data review
oReviews/Approves of Investigations/ OOS/ Change Controls to support Disposition. Also responsible for escalating the OOSs as necessary to MRB to support timely release of clinical supplies.
oFinal Disposition documentation and updates in Oracle.
Product Transition to Commercial / Registration to Validation / PAI Readiness
oEvaluate CMO Quality Systems to ensure compliance with commercial expectations
oMature the Quality Agreement(s) to commercial expectations
oProvide onsite support for registration batches
oEnsure source documents are approved and available
Collaborate with Partner on CMO Management and Performance oversight
oEstablish and maintain Quality Agreement(s)
oEvaluate CMO performance to Quality Agreement(s) expectations
oParticipate in Joint Development Committee and Face to Face meetings
Audit / InspectionSupport
oProvides both front & back room inspection support
oSupport for Post inspection activities
Strategizing for Product Development in support of filing and approval of IND, IMPD, CTA
oProviding guidance in product and specification development
Change Controls - execution
oQA Approver : Resolve gaps; Approve change plans; Approve classification; Approve strategy for GMP release and disposition strategy
Master s degree and 3- 4 years of relevant work experience, or Bachelor s degree in a scientific or allied health field (or equivalent degree) and 8+ years of experience in Quality Operations and Manufacturing within the biotechnology industry, or relevant comparable background. Must have worked with external contract manufacturers of sterile and or biologics products.
Gene Therapy technical expertise along with a deep knowledge of GMP guidelines and Quality expectations for clinical phase programs. Comprehensive knowledge of domestic and international GMP regulations and subsequent applications to pharmaceutical drug development.
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