Jeffrey Jackowski Email & Phone Number

Quakertown , Pa, Us

East Windsor, Nj - New Jersey, Us

• Pharmaceutical executive with 27 years experience in Operations, Quality Assurance and Regulatory Compliance in both plant and corporate environments.• Extensive experience with sterile injectables, emulsions, vaccines, blood fractionation, metered dose aerosols, solid/oral dose and creams ointments gels with respect to development, regulatory filings, technical validation and production.• Experience also included establishment and management of quality systems, supplier qualifications and compliance, technical validation and day to day operations. Served as key contact for companies during FDA inspections as well as FDA Office of Compliance. • Outstanding record of successful FDA Pre-Approval and GMP inspections. Strong working relationship with US FDA management assuring accurate and prompt evaluations of product submissions, review of sites and ultimate recommendation for approval. • Career achievements include:o Part of Glaxo Inc. US start-up team including successful construction, validation of main US manufacturing facility in Zebulon NC, culminating in FDA approval.o Successful remediation and validation of Ohmeda’s Anesthesia Manufacturing facility in Puerto Ricoo Successful remediation of facilities, policies, SOP’s and Product Validation for Wyeth and Centeon, resulting in resolution of FDA Consent Decrees at both companies.o Successful grassroots start-up of GeneraMedix Inc. which included establishment of all company Systems, Standard Operating Procedures, Technical Policies, as well all Supplier evaluations, qualification and FDA relationships.o Responsible for leading process for first FDA approvals for five key GeneraMedix Inc. suppliers and alliance partners in the USA, India, China and Turkey.

• Pharmaceutical executive with 27 years experience in Operations, Quality Assurance and Regulatory Compliance in both plant and corporate environments.•Member of Executive Startup Team (DAY 1 employee) and Vice President at GeneraMedix responsible for all Quality, Regulatory and FDA Field Compliance, Manufacturing Alliance Partner Plant Operations and Product Validation.• Extensive experience with sterile injectables with respect to development, regulatory filings, technical validation and production.• Experience also included establishment and management of quality systems, supplier qualifications and compliance, technical validation and day to day operations. Served as key contact for companies during FDA inspections as well as FDA Office of Compliance. • Outstanding record of successful FDA Pre-Approval and GMP inspections. Strong working relationship with US FDA management assuring accurate and prompt evaluations of product submissions, review of sites and ultimate recommendation for approval. •Successful grassroots start-up of GeneraMedix Inc. which included establishment of all company Systems, Standard Operating Procedures, Technical Policies, as well all Supplier evaluations, qualification and FDA relationships.o Responsible for leading process for first FDA approvals for five key GeneraMedix Inc. suppliers and alliance partners in the USA, India, China and Turkey.

Flint, Flintshire, Gb

Director of Site Quality Assurance for device company

New York, New York, Us

• Pharmaceutical executive with 27 years experience in Operations, Quality Assurance and Regulatory Compliance in both plant and corporate environments.• Previous employers include Glaxo Inc., Johnson & Johnson, Ohmeda, Centeon, Wyeth and GeneraMedix Inc. Most recent position was member of Executive Startup Team and Vice President at GeneraMedix responsible for all Quality, Regulatory and FDA Field Compliance, Manufacturing Alliance Partner Plant Operations and Product Validation.• Extensive experience with sterile injectables, vaccines, technical validation and production.• Experience also included establishment and management of quality systems, product quality, supplier qualifications and compliance, technical validation and day to day operations. Served as key contact for companies during FDA inspections as well as FDA Office of Compliance. • Outstanding record of successful FDA Pre-Approval and GMP inspections. Strong working relationship with US FDA management assuring accurate and prompt evaluations of product submissions, review of sites and ultimate recommendation for approval. • Career achievements include:Company representative and team leader to remediate and defend Quality Assurance and Quality Control concent Decree items to 3rd party and FDA representatives.Responsible for all Manufacturing QA activities at the Vaccine Site including evaluation/approval of all product complaints, in-process testing, deviations, investigations, retain evaluation, lead CHANGE CONTROL TEAM.o Successful remediation of facilities, policies, SOP’s and Product Validation for Wyeth , resulting in resolution of FDA Consent Decrees at the site.o Implemented a particle evaluation and glass inspection program that allowed the facility to resume manufacturing under concent decree. Hosted FDA inspection of Small Pox Vaccine

Us

Corporate Executive, responsible for assisting consent decree sites in US and Europe resolve all issues.Responsible for Corporate Complaint System, Quality Metrics, Performed Blood Site Audits. Remediated Quality issues at European Site.Received award for firm receiving FDA approval of a product that was thought to be dispositioned for reject. This reulted in a savings of millions of dollars to the company.

Responsible for Release of PRoduct for Marketplace, Customer Complaints, Stability Reports, Regulatory Complaince, Remediation of issues at all Company manufacturing sites and partner sites. Designed/Implemented all SOPs with respect to Quality Assurance Systems, Manufacturing PRocesses, Validation of Processes, Calibration, Maintenance for the plant resulting in ZERO FDA 483 pre approval inspection findings for new start-up liquid site.QA Responsible at new green site. Responsible for development of all systems, hiring of QA personel, implements all QA SYSTEMS resulting in ZERO FDA 483 items identified for start-up pharmaceutical gas site.

Repsonsible for QC Laboratory analysis for production, Validation of Production process of solid dosage, including manufacturing, packaging, internal, external quality audits and Researcj Quality Assurance systems.