Josephine Calabresi

Josephine Calabresi

QA Manager, Product Support at Novartis

Location
Greater New York City Area
Industry
Pharmaceuticals

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Josephine Calabresi's Overview

Current
  • QA Manager, Product Support at Novartis
Past
  • Supervisor, Quality Standards at Schering-Plough
  • Analytical Chemist at Schering-Plough
Education
Connections

258 connections

Josephine Calabresi's Summary

Quality Assurance professional with extensive expertise in Quality Control, FDA Quality Systems, and FDA/ICH Guidelines. Strong Consent Decree experience, responsible for developing several Global Quality Systems, e.g., Supplier Management, Investigations, Stability, and Sampling Plans. Significant experience in the pharmaceutical industry, working with liquids, creams, ointments, tablets, and raw materials. Strong knowledge of US and EU cGMP regulations, compendial requirements and Regulatory practices. Exceptional leadership and interpersonal skills to manage and lead individuals and interact with all levels of management.

Josephine Calabresi's Experience

QA Manager, Product Support

Novartis

Public Company; 10,001+ employees; NVS; Pharmaceuticals industry

January 2013Present (1 year 9 months) Suffern, NY

Manage the programs for Annual Product Reviews and Supplier Management.

Manager, Supplier Quality Assurance

Merck

Public Company; 10,001+ employees; MRK; Pharmaceuticals industry

April 2010November 2011 (1 year 8 months)

Managed critical suppliers on matters related to Quality issues, including coordinating investigations and monitoring supplier's operational and quality performance. Worked directly with the suppliers in strengthening their Quality Systems, and develop corrective actions to audit observations. Authored technical Global Quality documents for the Global Supplier Management System, which served as guiding principles for all domestic and international sites dealing with suppliers.

Manager, Global Quality Sytems

Schering Plough

Public Company; 10,001+ employees; MRK; Pharmaceuticals industry

September 2001April 2010 (8 years 8 months)

Managed several Global Quality System overseeing 68 sites worldwide. Responsible for Stability, Specifications, Sampling, Contractors and Suppliers, Investigations. Worked with the sites in assessing GMP status and improving their quality systems. Sites manufacture human and animal health products including APIs, vaccines, antibiotics, drug products marketed as solid dosages, creams and ointment, syrups, injectables and inhalers.
Consent Decree Activities (Schering-Plough Corporation)
• Facilitated the creation of Global Quality Policies as they pertain to the FDA’s Systems Inspection Guidance for the Quality Assurance and Laboratory Systems. Interacted with Subject Matter Experts and industry consultants in the creation of the Quality Standards.

Manager, Quality Standards

Schering-Plough

Public Company; 10,001+ employees; MRK; Pharmaceuticals industry

September 1998September 2001 (3 years 1 month)

Managed a group of nine employees, operating with a budget of over $990,000. Responsible for Stability Program, Reference Standards Program, Sampling Plans, Statistical Review of Stability Data, Reserve Samples, Reserve Sample Visual Inspection Program, Review and Approve Change Authorizations.

Supervisor, Quality Standards

Schering-Plough

Public Company; 10,001+ employees; MRK; Pharmaceuticals industry

May 1984September 1998 (14 years 5 months)

Supervised the QC Marketed Product Stability Program and the Product Improvement (R&D) Stability Program for NJ manufacturing, ensuring their timely submission of Annual Reports to FDA. Responsible for generating statistical analyses of the stability data and made recommendations on specifications, expiration dating and storage labeling. Products included Rx and OTC, Human and Animal Health.
• Managed a $1MM project in the renovation of the stability and reserve sample storage area. Worked with purchasing, engineering, and sub-contractors during the design, construction and validation phases.
• Participated directly with FDA inspectors during inspections of the Stability Program and reserve samples storage areas.
• Supported all domestic labs, Regional Sites and International Subsidiaries for the Reference Standard Program that included over 150 compounds. Procured, certified, and dispensed the standards to all the sites and several Compendial organizations, such as USP, EP, BP and JP, as well as the WHO.
• Responded to FDA 483’s, implemented corrective actions, and prepared documents for new NDAs and supplements.

Analytical Chemist

Schering-Plough

Public Company; 10,001+ employees; MRK; Pharmaceuticals industry

January 1980May 1984 (4 years 5 months)

Analytical Chemist working with various dosage forms, e.g., raw materials, tablets, creams, ointments, and aerosols.

Josephine Calabresi's Skills & Expertise

  1. GMP
  2. FDA
  3. Quality System
  4. Pharmaceutical Industry
  5. Validation
  6. CAPA
  7. Quality Control
  8. Quality Assurance
  9. Consent Decree
  10. Change Control
  11. GxP
  12. Process Improvement
  13. LIMS
  14. GLP
  15. Investigation
  16. Stability Operations
  17. Supplier Quality Management
  18. Vaccines
  19. 21 CFR Part 11
  20. Regulatory Submissions
  21. Technology Transfer
  22. Quality Auditing
  23. Specifications
  24. R&D
  25. Regulatory Affairs
  26. GAMP
  27. Regulatory Requirements
  28. Biopharmaceuticals
  29. Reference Standards
  30. Trend Analysis
  31. Trackwise
  32. Sop
  33. USP
  34. FDA GMP
  35. Deviation Management
  36. Sampling Plans
  37. Training
  38. Annual Product Review

View All (38) Skills View Fewer Skills

Josephine Calabresi's Education

Montclair State University

BS, Chemisty

Fluent in Italian and Spanish

Activities and Societies: Member of NJPQCA

Josephine Calabresi's Additional Information

Groups and Associations:

Member of NJPQCA since 1999

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