Manager, Quality Assurance Operations

Responsibilities

• Manage, review, and track production and analytical records to support disposition of raw/starting materials, intermediates, drug products, and other materials.
• Review and approve batch records and test data in compliance with regulatory requirements and Company standard operating procedures (SOPs).
• Oversee proper execution of GMP operations including material control, production, and testing activities.
• Quality Assurance (QA) oversight of nonconformances, including lab/OOS investigations, deviations, corrective and/or preventive actions, and ensure proper product impact assessment.
• Provide QA oversight of internal GxP operations and act as QA with external test laboratories or manufacturing organizations.
• Provide QA guidance in the development of product and material quality attributes.
• Review and approve analytical method/process qualification, verification and validation protocols and reports in collaboration with subject matter experts.
• Ensure proper training of applicable departments in accordance with Fate SOPs and applicable regulations.
• Review and approve protocols and reports to support stability and other GMP studies.
• Review and approve research reports.
• Review and approve batch records and analytical method SOPs in Fate’s established eDMS.
• Contribute to the revision, update, and approval of SOP’s.
• Manage, train, and mentor team in support of data review and analysis and internal investigations.
• Prepare teams responsible for data integrity and collection for inspection readiness.
• Support QA Management with various projects as needed.

Qualifications

• Bachelor’s or advanced degree in a relevant scientific area with a minimum of 6 years of Quality Assurance experience in a cGMP regulated manufacturing environment.
• Experience with assay development, validation and/or quality control for viral or biological drug products is required.
• Strong understanding and knowledge of GXP, ISO, and ICH concepts and guidelines, and implementation of GXP in a Phase appropriate manner in conformance to US & EU standards.
• Strong understanding in material disposition, batch record review, NCMR review, QA observation for manufacturing activities, and material/product disposition requirements.
• Must have a strong understanding of OOS investigation procedures, deviations, CAPA’s and change controls.
• Demonstrated ability to work independently, prioritize, and complete activities in a timely manner; self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Strong verbal and written communication skills and ability to work cross-functionally in a positive and collaborative manner.
• Experience / knowledge in cell-based assays is highly preferred.

Working Conditions and Physical Requirements

• May require occasional travel.
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. 

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
• The anticipated salary range for this role is $120,000 - $140,000.