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Manager / Senior Manager, Quality Assurance

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POST DATE 9/18/2016
END DATE 11/13/2016

Five Prime Therapeutics, Inc. South San Francisco, CA

South San Francisco, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


div id="contentwrapper" p strong Five Prime Therapeutics, Inc.  /strong (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to alter the tumor microenvironment to enhance tumor cell killing. Our company has a growing portfolio of product candidates. /p p We currently have three protein therapeutics in clinical trials: /p ul li style="text-align: justify;" Cabiralizumab (FPA008) in pigmented villonodular synovitis (PVNS) and in combination with Opdivo in multiple cancers /li li style="text-align: justify;" FPA144 in FGFR2b over-expressing gastric cancer /li li style="text-align: justify;" FP-1039 in mesothelioma /li /ul p On the strength of our unique discovery platform and capabilities, we have entered into strategic collaborations with leading global pharmaceutical companies, including Bristol-Myers Squibb, UCB Pharma and GlaxoSmithKline. /p p FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at a href="/" /a . /p h2 Position: /h2 p FivePrime Therapeutics, Inc. is seeking a motivated and ambitious individual to join the Quality team as a Manager of Quality Assurance.  The Quality Assurance Manager is an advanced level position requiring hands-on QA experience in a biotech manufacturing environment. /p p The individual will be responsible for the quality aspects of early- and late-stage clinical and drug substance and drug product manufacturing at contract manufacturers and for product disposition, working independently and with minimum supervision. This position will also help develop internal Quality Systems, ensuring compliance to quality objectives and regulatory requirements.  The position reports to the Vice President of Quality. /p p Responsibilities will include the following: /p ul li style="text-align: justify;" Provide QA support in the development, technology transfer, scale-up, establishment, validation and manufacturing of drug processes of clinical drugs at CMOs. /li li style="text-align: justify;" Provide effective QA support for the review disposition of clinical lots. /li li style="text-align: justify;" Review and approve Production Records, Specifications, Test Methods, Validation Protocols and Stability Protocols. /li li style="text-align: justify;" Perform QA Review of master batch records, executed batch records, test results and certificates of Analysis from CMOs, including any deviation and investigation reports related to lot release for drug substance or drug product as assigned. /li li style="text-align: justify;" Act as a compliance resource to provide guidance and assistance towards resolution of simple to complex deviations, quality investigations, lab investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products. /li li style="text-align: justify;" Work directly with operating entities (internal and CMOs) to ensure that clinical drug substance and drug product meet all required quality standards and specifications. /li li style="text-align: justify;" Ensure that procedures and practices at CMOs adhere to cGMPs and regulatory requirements of FDA, EMA and other regulatory agencies, as required. /li li style="text-align: justify;" Coordinate and communicate with internal SMEs and CMOs on quality related issues to facilitate corrections, clarifications, and resolution of associated quality issues in a timely manner. /li li style="text-align: justify;" Partner with stakeholders such as Legal, Regulatory Affairs, Clinical Operations, etc. regarding compliance issues and provide compliance guidance to all audited parties to encourage process improvement; serve as an expert in the interpretation of quality/ regulatory requirements and expectations. /li li style="text-align: justify;" Ensure compliance with quality systems such as change control, quality investigations, and CAPA resolutions. /li li style="text-align: justify;" Participate in due diligence visits and/or audits for the qualification of new CMOs as assigned /li li style="text-align: justify;" Plan, schedule and perform QA compliance audits (internal and external) as assigned. /li li style="text-align: justify;" Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented. /li li style="text-align: justify;" Prepare, review and approve CMC sections of regulatory filings as assigned. /li li style="text-align: justify;" Initiate or revise internal SOPs applicable to internal functions as well as outsourced functions. /li li style="text-align: justify;" Provide internal GXP training as required /li li style="text-align: justify;" Represent the quality assurance department on cross functional project teams. /li /ul