Summary
Overview
Work History
Education
Skills
Awards
Certification
Timeline

Regina Gagan

Attleboro,MA

Summary

Skilled quality assurance professional with proven record of ensuring high standards in product and process integrity. Strong focus on team collaboration and delivering results, adaptable to changing needs. Expertise in quality assurance, regulatory compliance, and continuous improvement initiatives. Known for reliability, problem-solving abilities, and effective communication.· Experience with various LMS, DMS, and eQMS systems including Master Control, Plateau and SmartSolve (Pilgrim).

Overview

24
24
years of professional experience
1
1
Certification

Work History

Quality Assurance Manager, Compliance/Training Support

AVECIA, (Nitto Denko Avecia Corporation)
12.2024 - Current
  • Implemented new role-based training system
  • Led the improvement and execution of a New Hire Orientation GMP training program, streamlining the onboarding process.
  • Implemented Master Training Curriculums, Individual Training Plans, On-the-Job Training Plans and Trainer Qualifications for the site.
  • Tracking training completion and reporting metrics to management
  • Oversee training staff across multiple departments

Quality Assurance Team Leader, Compliance/Training Support

AVECIA, (Nitto Denko Avecia Corporation)
12.2021 - 12.2024
  • Facilitating training assignments within the LMS along with functional area managers
  • Identifying training needs by consulting with stakeholders in multiple GMP departments
  • Develop and deliver GMP compliance training increasing staff adherence to FDA guidelines
  • Managed Training documentation, ensuring accurate tracking
  • Oversee QA training and development staff
  • Led the creation and implementation of annual GMP training, enhancing company-wide compliance.

Quality Assurance Team Leader

AVECIA, (Nitto Denko Avecia Corporation)
10.2019 - 12.2021
  • Acted as QA lead on critical pre-PPQ and PPQ projects, ensuring regulatory compliance
  • Mentored a team of QA Specialists, increasing team performance in managing GMP activities
  • Supported customer and regulatory audits, contributing to successful audit outcomes
  • Reviewed and approved procedures, deviations/OOS reports, and product specifications

Senior Quality Assurance Specialist

AVECIA, (Nitto Denko Avecia Corporation)
08.2013 - 10.2019
  • Led QA for multiple clinical development teams, ensuring timely project completion and FDA compliance.
  • Managed internal audits and batch record reviews, maintaining high standards of cGMP compliance.
  • Contributed to regulatory filings by providing critical project information, ensuring accurate documentation.

Quality Assurance Technical Writer – Contract Position

CITRA LABS, LLC
02.2013 - 08.2013
  • Responsible for reducing backlog and updating the CAPA system for a small biotechnology company developing citrate based anti coagulants.
  • Audited Quality Standard Operating Procedures, identified gaps, recommended corrective actions and performed additional tasks as required.
  • Trained in multiple new regulations including 21 CFR Part 820, ISO 13485 & MDD 93/42/EEC.

Quality Assurance Engineer

GENZYME DRUG AND BIOMATERIAL R&D
01.2008 - 01.2012
  • Company Overview: (Formerly GelTex Pharmaceuticals, acquired by Genzyme in 2000)
  • ·Supported the startup of a newly constructed small scale manufacturing facility located in Waltham, MA. Managed all quality activities throughout the GMP manufacturing process for API and solid oral dosage forms.
  • Key point of contact and project representative supporting manufacturing, R&D, and QA from pre-manufacturing through release of product at CDMO's.
  • Developed and implemented QA plans to support new product manufacturing campaigns, raw material sampling, and product testing; ensuring FDA Regulatory guidelines and internal compliance requirements were adhered to.
  • Audited Quality Standard Operating Procedures against Corporate Key Points of Compliance, identifying gaps, recommended and implement actions, secure leadership buy in
  • Participated in the qualification and validation for the Deviation and CAPA system.

Senior Quality Assurance Specialist

GENZYME DRUG AND BIOMATERIAL R&D
05.2001 - 01.2008
  • Company Overview: (Formerly GelTex Pharmaceuticals, acquired by Genzyme in 2000)
  • Supported the startup of a newly constructed small scale manufacturing facility located in Waltham, MA. Responsible for oversight of all manufacturing operations internally and support of Contract Manufacturing Operations sites, developed and implemented policies, trained new employees, and maintained GMP training documentation.
  • Participated in numerous project teams as the Quality Assurance representative, attending cross-functional meetings to discuss manufacturing and analytical issues, ensure project timelines were met, coordinate documentation both internally and externally, and resolve issues as they arose.

Education

Associate of Science - Liberal Arts

NORTHEASTERN UNIVERSITY, Boston, MA

Skills

  • FDA cGMP adherence (21CFR 210 & 211, Part 11 and ICH Q7)
  • Quality Systems
  • Training & Development
  • Team leadership
  • Comprehensive auditing skills
  • Continuous Improvement

Awards

Genzyme Vice President Award (2007) “Outstanding effort in setting up the QA Systems necessary to support GMP manufacturing operations, as well as providing expertise in drafting the new facility SOP’s”, 

Genzyme Vice President Award (2001) “Acknowledgement of her outstanding contribution and commitment to supporting Renagel Quality and the 800mg relaunch”

Certification

Certificate in Train the Trainer

Timeline

Quality Assurance Manager, Compliance/Training Support - AVECIA, (Nitto Denko Avecia Corporation)
12.2024 - Current
Quality Assurance Team Leader, Compliance/Training Support - AVECIA, (Nitto Denko Avecia Corporation)
12.2021 - 12.2024
Quality Assurance Team Leader - AVECIA, (Nitto Denko Avecia Corporation)
10.2019 - 12.2021
Senior Quality Assurance Specialist - AVECIA, (Nitto Denko Avecia Corporation)
08.2013 - 10.2019
Quality Assurance Technical Writer – Contract Position - CITRA LABS, LLC
02.2013 - 08.2013
Quality Assurance Engineer - GENZYME DRUG AND BIOMATERIAL R&D
01.2008 - 01.2012
Senior Quality Assurance Specialist - GENZYME DRUG AND BIOMATERIAL R&D
05.2001 - 01.2008
NORTHEASTERN UNIVERSITY - Associate of Science, Liberal Arts

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