Summary
Overview
Work History
Education
Skills
Campus Involvement
References
Timeline
Generic

Annalise DiFolco

Hudson,MA

Summary

Motivated Senior Specialist in Supplier Quality, adept at process optimization and risk management. Proven track record in executing impactful quality initiatives and fostering collaborative teamwork. Skilled in Supplier Quality Management, driving significant improvements in material qualification and change implementation, ensuring compliance and enhancing operational efficiency.

Overview

6
6
years of professional experience

Work History

Senior Specialist, Supplier Quality

Bristol Myers Squibb
01.2023 - Current
  • Collaborated across cross-functional teams to support clinical and commercial campaigns scheduled for the site.
  • Lead material re-certification for materials on reduced testing, and facilitated monthly meetings to track actions on annual testing.
  • Support the Supplier Change Notification Process via weekly triage and impact assessments.
  • Conducted data verification of the Supplier Quality Management module via the approval and modification of material qualification, organization, and site/function approval records.
  • Execute quality efforts, such as NMR approvals, site impact assessments, and change control support.
  • Act as the QA deviation approver for external deviations related to consumable material defects.
  • Support optimization efforts, such as material classification reviews and Level 1 sterility projects.
  • Implement corrective actions as per Corrective and Preventive Actions (CAPA).
  • Write and review risk assessments in compliance with global quality procedures.
  • Participated in the audit of a supplier's warehouse and consumable manufacturing facilities.
  • Trained to support backroom activities during BMS site audits.
  • Participate in Quarterly Business Reviews with top suppliers, providing data on the Supplier Change Notification Process.
  • Manage contractor responsibilities for the team, and ensure tasks are closed on time.
  • Cross-trained biologics QA team on quality processes such as SCN, Material Qualification, and Reduced Testing.

QA Supply Operations Associate, QA Supply Operations

Bristol Myers Squibb
09.2020 - 01.2023
  • Collaborated with various supply chain teams to execute quality actions, such as material qualification, incoming inspection, and material release.
  • Utilized quality perspective to assess impact of Supplier Change Notifications for the site
  • Communicated outside the organization to build productive functional relationships among various suppliers, partners, and procurement teams to receive material documentation in an efficient manner
  • Reported data analytics weekly to a team of vested individuals using TIBCO Spotfire software

Consultant, Manufacturing Sciences & Technology

Bristol Myers Squibb
04.2019 - 09.2020
  • Supported the implementation of a new global qualification SOP to update and streamline the qualification of legacy raw materials and consumables used to produce drug products at the company’s biologics sites
  • Collaborated with functional areas globally to communicate changes in qualification and request additional documentation

Education

MBA - Concentration in Healthcare Management

University of Massachusetts Lowell
03.2025

Bachelor of Science - Biology, Minor in Education

University of Massachusetts Amherst
12.2018

Skills

  • Supplier Quality Management (SQM)
  • Process Optimization
  • Risk Management Strategy
  • Change Implementation Skills
  • Collaborative Teamwork
  • Knowledge Sharing

Campus Involvement

  • Alpha Phi Omega, National Service Fraternity, 09/17, 12/18, Worked with the Kappa Omicron chapter at UMass to serve the surrounding local communities. Helped to chair social events and participated in multiple service projects.
  • Isenberg Women in Business Club, Fall 2015, Spring 2018, Networked with women within the management school and attended presentations from professionals across multiple industries.

References

References available upon request.

Timeline

Senior Specialist, Supplier Quality

Bristol Myers Squibb
01.2023 - Current

QA Supply Operations Associate, QA Supply Operations

Bristol Myers Squibb
09.2020 - 01.2023

Consultant, Manufacturing Sciences & Technology

Bristol Myers Squibb
04.2019 - 09.2020

MBA - Concentration in Healthcare Management

University of Massachusetts Lowell

Bachelor of Science - Biology, Minor in Education

University of Massachusetts Amherst

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Annalise DiFolco