Summary
Overview
Work History
Education
Skills
Websites
Leadership And Professional Memberships
Areas Of Expertise
Timeline
Generic

JENNIFER GOODMAN

Springtown,PA

Summary

An experienced, effective, and results-oriented Quality leader with diverse Quality Management Systems, Quality Compliance, and cGMP manufacturing experience in the chemical, pharmaceutical, medical device, and distribution industries. Expert in Corporate/Internal Auditing and Inspection Readiness. Excels at all parts of Supplier Relationship Management including auditing, corrective action, Quality Agreements, and qualification.

Overview

19
19
years of professional experience

Work History

Senior Director, Quality

Avantor
01.2018
  • Global owner of Supplier Quality Management, Quality Auditing Function, and QMS Development within a $6B global provider of critical products and services to the life sciences, education, government, advanced technologies, and applied materials industries.

Senior Director, Quality and Regulatory Affairs

Puritan Products
01.2016 - 01.2018
  • Led and directed Quality Assurance, Quality Control, and Regulatory Affairs groups
  • Reported to CEO, member of executive leadership team
  • Avantor purchased Puritan in 2017.

Associate Director, Quality Systems Excellence

B. Braun Medical Inc
01.2013 - 01.2016
  • Created the BBMI Corporate Quality System Model which included identifying 22 quality system elements applicable to the company, socializing my strategy to executive management at corporate and local sites, and engaging quality personnel at the sites to implement the strategy.

Global Manager, Quality

Avantor Performance Materials
01.1999 - 01.2013
  • Developed new Supplier Auditing Program
  • Planned, executed, investigated, and closed over 225 audits of critical suppliers of raw materials, components, CMOs, contract labs, and packaging
  • Performed new qualification, for-cause, and routine maintenance audits.

Education

Master of Business Administration -

Lehigh University
Bethlehem, PA

Master of Science in Pharmaceutical Manufacturing Engineering -

Stevens Institute of Technology
Hoboken, NJ

Bachelor of Science in Chemistry, Bachelor of Arts in Psychology -

Muhlenberg College
Allentown, PA

Skills

  • Collaborative Leadership
  • Culture Transformation
  • Policy Development
  • Negotiation and Conflict Resolution
  • Employee Coaching and Mentoring
  • Decision-Making
  • Legal and Regulatory Compliance
  • Key Performance Indicators
  • Organizational Development
  • Team Building and Motivation
  • Verbal and written communication
  • Staff Development

Leadership And Professional Memberships

  • Rx-360 Member of the Board of Directors 2024. Leadership positions in Rx-360 Audit Operations Group, Supplier Quality Working Group, and Supply Chain Security Steering Committee. Presenter at Rx-360 2023 Patient Safety Conference, Washington, DC.
  • Presenter at 2024 DCAT Education Series, March 2024 New York, NY “De-Risking of Supply Chain through Effective Utilization of a Joint Audit Program Approach”
  • Parenteral Drug Association (PDA) Supply Chain Management Interest Group, Quality Systems Interest Group, and Quality Risk Management Interest Group;
  • American Society for Quality (ASQ) Certified Quality Auditor (CQA); BioPhorum Operations Group (BPOG); International Pharmaceutical Excipients Council (IPEC)

Areas Of Expertise

Lean Sigma tools and methodologies; applying ISO 9001:2015/14001/13485, global pharmaceutical, API, Excipient, Food, MDR, and IVDR regulations and guidelines including FDA, MHRA, EMA, ChP; data-driven decision making; relationship building; change management; coaching and mentoring; strategic planning; effective and agile communication., MS Office software, SAP, Master Control, ETQ

Timeline

Senior Director, Quality

Avantor
01.2018

Senior Director, Quality and Regulatory Affairs

Puritan Products
01.2016 - 01.2018

Associate Director, Quality Systems Excellence

B. Braun Medical Inc
01.2013 - 01.2016

Global Manager, Quality

Avantor Performance Materials
01.1999 - 01.2013

Master of Business Administration -

Lehigh University

Master of Science in Pharmaceutical Manufacturing Engineering -

Stevens Institute of Technology

Bachelor of Science in Chemistry, Bachelor of Arts in Psychology -

Muhlenberg College

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JENNIFER GOODMAN