Paul A. Steiner, PhD, CQA

Experience

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  Affymetrix

  Jan 1999 - Jan 2005

  Sr. Staff Quality Manager

  • Investigated and resolved an intermittent IVD product defect resulting in yield improvement by 900% annually.• Transformed the quality system from R&D to QSR/ISO 13485 compliance through creation of SOPs and training of personnel, enabling entry into FDA-regulated market. • Instituted quality metrics for supply chain to assess manufacturing robustness resulting in reduced non-conforming raw materials.• Improved product yield by 50% through discovering the problem and implementing a new critical raw material QC specification test method. Show less

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  Quality Assurance & Regulatory Compliance; Resins, Adhesives & Fiber Reinforced Composites,

  Jan 2005 - now

  Consultant: FDA Regulatory Compliance: QA for Pharma & Device & Expert in Adhesives/Fiber Composites

  Provide consulting services in regulatory compliance (QA) as it relates to pharmaceuticals and medical devices (GMP, GCP, GLP, & GPVP). In addition my expertise covers design/process control in a regulated environment. Additional expertise in resins, adhesives, fiber reinforced composites for all applications with emphasis on medical devices, aerospace and advanced application.

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  Gilead Sciences

  Jan 2005 - Jan 2006

  Sr. Mgr. QA

  • Cross-trained personnel to ensure a 3-month supply of product to meet market demand, resulting in increased sales.• Collaborated with API contractors for continuous quality improvement which reduced OOS and OOT conditions, deviations, and CAPAs (quality metrics), resulting expedited product release and increased lot acceptance by 25%.• Led contract manufacturing of small molecules and biologics for commercial and IMP APIs, releasing 450+ lots/year with existing staff. • Hosted an unannounced PAI inspection, resulting in no observations from the FDA.• Developed and validated with QC on new test methods and stability protocols which improved reliability by 15%.• Collaborated with CMC on annual updates of regulatory filings to maintain compliance. Show less

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  Allergan

  Jan 2006 - Jan 2007

  Sr. Manager Technology & QA

  • Transferred two new biologics from development to commercial product to enable new product launches and strategic partnerships. • Improved yield by 30% for existing products including Class III medical devices. • Generated and presented quality metrics to senior management highlighting areas for improvement, which improved quality and reduced costs by $1M annually.

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  FibroGen Inc.

  Jan 2007 - Jan 2012

  Associate Director Quality Assurance

  • Strategic leadership on cross-functional teams tasked with manufacture of FibroGen US/China clinical stage product, building the foundation to launch lead IMP in China as a domestic product prior to US NDA approval.• Provided GXP QA leadership on the company’s lead IMP which enabled completion from phase 2 and FDA approval to enter phase 3 clinical trials.• Established an API and drug product manufacturing facility to comply with China’s SFDA requirements to establish a domestic presence in their country.• Qualified CMOs for manufacturing to support Chinese clinical trials and global clinical supply to reduce manufacturing costs. Show less

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  Vivus Inc

  Jan 2012 - Jan 2012

  Director of Quality

  • Designed and implemented a GXP compliant QA organization which enabled the company to launch new NDA product for commercial market announcement.• Assured GMP quality standards which resulted in safe and effective product for patients.• Established complaint tracking, trending, and reporting process to be compliant with FDA regulations.• Created a product returns process which improved customer satisfaction and reduced patients’ co-pays.• Hosted four regulatory inspections which helped kept the company in compliance.• Initiated and executed annual audit plan for all contractors including CRO, CMO, CTL, and 3PL which ensured regulatory compliance. Show less

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  NGM Biopharmaceuticals

  Oct 2014 - Feb 2017

  Director of Quality Assurance

  Establishing and manage all aspects of the Quality System and GxP regulatory compliance activities with a focus on continuous improvement.