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Jeff Jackowski  

Senior Associate

Jeff has over 35 years of experience in quality assurance and regulatory compliance within the pharmaceutical and biopharmaceutical, industries .  He is an expert in design and implementation of quality management systems, validation, and all related GXP subjects.

Jeff has been an integral part of managing two FDA consent decrees.  He has managed PAI projects in Europe, US and Asia.  His range of experience spans across the spectrum of solid dosage, liquids, aerosols, OTC, Injectable and biotechnology products.   

 

Jeff’s  key skills and experience includes:

  • Worked as Vice President of Quality, Director of QA for several US based international Pharmaceutical companies (including Aurobindo, Sun pharma, Genera Medix, Nice-Pak/PDI, Wyeth-Ayerst, and Aventis)

  • Worked with the FDA Compliance Office to remove a manufacturing facility from Import Alert

  • Worked directly with FDA to streamline import releases from 7-10 days to 3 or less 

  • Developed corporate policies, procedures, and implemented QMS

  • Improved the overall compliance of the Pharmacovigilance department  

  • Implemented a formal metrics program

  • Performed due diligence and audits internationally

  • Hosted several successful  FDA and international regulatory agency inspections

  • Prepared sites for FDA inspection and achieved observation free FDA inspections results

  • Decreased customer complaints from 9 to 0.002% per 100,000 units sold

  • Managed global Data Integrity programs

  • Headed and coordinated FDA consent decree remediation

  • Headed and coordinated warning letter remediation resulting in successful outcome

  • Managed global teams to design and launch document management systems