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Job Title: Quality Manager, Gene Therapy

Job Description:

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.

RESPONSIBILITIES:

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

oInvestigation guidance

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

oSME Responder

oPreparation activities

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

oOwner /Assessor

oQA Approver : Resolve gaps; Approve change plans; Approve classification; Approve strategy for GMP release and disposition strategy


Minimum qualifications:

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.



* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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