Summary
Overview
Work History
Education
Skills
Timeline
Barbara Huff

Barbara Huff

Quaker Hill,CONNECTICUT

Summary

Results-driven leader skilled at guiding high-performing teams and implementing strategic initiatives to drive business success. Well-regarded for fostering a collaborative environment and consistently achieving measurable milestones. Demonstrates strong leadership qualities and adaptability to meet evolving business requirements.

Overview

39
39
years of professional experience

Work History

Sr. Director of Quality

Pfizer Clinical Research Unit
01.2020 - 01.2023
  • Optimized project timelines by effectively delegating tasks and prioritizing workload among team members.
  • Cultivated a culture of innovation by promoting creative thinking and encouraging employees to take calculated risks in pursuit of solutions.
  • Developed strong relationships with key industry partners, fostering collaboration and mutual growth opportunities.
  • Directed design and execution of business transformation initiatives to drive performance, profit optimization and growth opportunities.

Quality Culture Director, Clinical Development Quality (CDQ)

Pfizer Groton CT
01.2017 - 01.2020
  • Created programs and communications to ensure the culture of quality was a key element in the conduct of clinical trial management.

Senior Compliance Manager

Pfizer Groton CT
01.2002 - 01.2017
  • Managed Quality Management Systems:
  • Owned the Investigation and Notification to Management processes, Coordinated and led internal audits, Created and managed the QA training program, lead trainer for Human Error Reduction, Inspection Readiness, SOP writing and Root Cause Analysis programs. Managed the development, documentation, and coordination of training activities across the QA organization.Led the Quality Operations for the GMP manufacturing of solid and liquid dose clinical products.
  • Led quality investigations, Supported inspection readiness activities, Reviewed batch records and Created and led annual GMP training.


  • Supervised 6 colleagues and 2 contract employees in the QA Batch Record Review group.


Analytical Scientist

Pfizer Groton CT
01.2000 - 01.2002
  • Reviewed cGMP documentation for the release of non-active components, and initial release of drug products and API.
  • Laboratory representative on the Groton Compliance Enhancement Group (CEG). Worked with teams to write SOPs to ensure compliance to cGMPs and to develop efficient workflows.
  • Maintained metrics of quality issues found during review of notebooks, and provided feedback to issues on a monthly basis to laboratory colleagues.

Formulation Scientist

Pfizer Groton CT
01.1994 - 01.2000
  • Initiated and coordinated training program for Solids group new hires which included an intensive course discussing the theory of formulating, hands-on training and improvement in the mentoring system.
  • Authored “Best Practices Handbook” which detailed instructions on the use of equipment in the developmental laboratory, safety guidelines, and general laboratory information.
  • Responsible for the “data-mining” of stability information found in staff reports and the development of a Microsoft Access database to store the data.
  • Formulated solid dosage forms. Experience in use of various equipment, e.g. Roller compactor, wet mills, tablet presses, high shear granulators, and microfluidizer. Performed analytical testing, as needed.

Sr. Research Scientist

Sterling Pharmaceuticals
01.1986 - 01.1994
  • Utilized capillary electrophoresis (CE) as a separation technique for a variety of materials such as drugs and their metabolites, particles, serum proteins and cell organelles. Modeled physical parameters of drug delivery systems.


Analyst

Ayerst Pharmaceuticals
01.1984 - 01.1986
  • Developed HPLC assays and dissolution testing for various drug formulations. Performed HPLC analysis of formulation placed on long-term stability.

Education

Bachelor of Science - Chemistry

Hartwick College, Oneonta, NY
05.1984

Skills

  • Guiding diverse teams effectively
  • Organizational culture change
  • Collaborative team management
  • Policy formulation

Timeline

Sr. Director of Quality - Pfizer Clinical Research Unit
01.2020 - 01.2023
Quality Culture Director, Clinical Development Quality (CDQ) - Pfizer Groton CT
01.2017 - 01.2020
Senior Compliance Manager - Pfizer Groton CT
01.2002 - 01.2017
Analytical Scientist - Pfizer Groton CT
01.2000 - 01.2002
Formulation Scientist - Pfizer Groton CT
01.1994 - 01.2000
Sr. Research Scientist - Sterling Pharmaceuticals
01.1986 - 01.1994
Analyst - Ayerst Pharmaceuticals
01.1984 - 01.1986
Hartwick College - Bachelor of Science, Chemistry

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