Edward Fennessy

Experience

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  Pfizer Pharmaceuticals

  May 1988 - Feb 2007

  Manager/TL Quality Operations

  Held positions with increasing responsibility in various departments and locations including Manager/TL at Parsippany, NJ, Groton, CT, and Brooklyn, NY supporting transfer of RX Oral Solids and Liquids to OTC. Led the QA Inspection and Supplier Quality Initiatives to mitigate production and quality concerns thereby reducing customer complaints and improve operational efficiency. Implemented a new Quality Engineer Department to address overdue customer complaints, repeat vendor and supplier quality concerns, and manufacturing delays due to unresolved in-process quality issues. Increased operational efficiency and improved regulatory compliance, reduced product release delays, and eliminated 45 FTE positions. Led the Stability Monitoring and Finished Good laboratories for testing of API and RM materials (powder, liquid and solid dose) utilizing HPLC, TLC, AA, IR, FTIR, UV, microbiological and other analytical methodologies. Show less

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  Johnson & Johnson

  Feb 2007 - Jan 2009

  Dir/TL Quality Operations

  Held concurrent responsibility for overseeing Contract Manufacturing Quality Assurance, incoming material inspections, and in-process control inspection/deviations. Monitored quality operations of 24/7 site facility, leading five direct and 40 indirect reports in the development of various pharmaceutical products. Accountable for the tech transfer of products to other facilities, as well as support FDA activities. Saved $30M by developing quality standards and FMEA Supplier Quality Management program. Established an effective quality organization, reducing FTE by 45 personnel saving $1.5M annually and improving product release cycle times by 70%. Show less

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  Home Maide Incorporated

  Feb 2009 - Aug 2019

  President/Co-Owner

  Direct all strategic planning and continuous improvement efforts across manufacturing, packaging, sales and distribution of gluten free products. Implement initiatives to propel market share by offering high quality product with extended shelf life at modest COGs to large distribution channels, such as Walmart, Costco, and BJs. Oversee various financial functions and P&L accountability.

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  GERITREX CORP

  Mar 2017 - Jul 2018

  Site Leader

  Ensured the successful transition of legacy pharmaceuticals products and personnel during the sale of oral liquid products to Geritrex. Directed all quality initiatives, overseeing Regulatory, Analytical, and Microbiological Laboratory, Validation, QA, Customer Complaints, Recall and Market Actions, and FDA/DEA/EPA/NYS BOH point of contact.

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  Mallinckrodt Pharmaceuticals

  Mar 2019 - Feb 2023

  Site Director, Quality and Regulatory Affairs

  Oversee the Quality Assurance, Regulatory, Stability, Control Laboratory and Compliance of a 450 personnel facility manufacturing and packaging 6 billion doses annually of liquid and solid dose Schedule II and III pharmaceutical products. Direct contact with FDA and related regulatory agencies.

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  Regeneron

  Oct 2023 - now

  Associate Director IOPS Quality Assurance

  Direct Internal Fill and Finish Quality Assurance activities in support of Material and Supplier Quality qualification and commissioning of new Regeneron facility located in East Greenbush, NY.