NANCY CAPUANO
Marblehead,MA
Summary
Strategic-thinking leader with a proven track record in building and leading efficient teams, prioritizing people development. Experienced in implementing innovative strategies to drive organizational growth and achieve business objectives. Skilled in identifying opportunities for process improvement and implementing effective solutions. Adept at fostering a collaborative and inclusive work environment that promotes employee engagement and enhances overall team performance.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Director, GMP Operational Quality
Vertex Pharmaceuticals
08.2024 - Current
- Lead a Quality team - primarily responsible for providing quality oversight and disposition for Manufacturing Operations (Cell and Gene Therapy)
- Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
- Develop and maintain compliant Quality processes to support GMP activities
- Provide QA support for GMP investigations/associated CAPAs, change controls, and risk assessments
- Track performance metrics and report to Quality Leadership team; develop tactics to improve performance outcomes
- Participate in inspection readiness activities and provide support for Quality development discussions as necessary during site inspections
- Enable team to achieve team goals/objectives and enable their individual career development.
Associate Director, GMP Operational Quality
Vertex Pharmaceuticals
06.2023 - 08.2024
- Lead a Quality team - primarily responsible for providing quality oversight and disposition for Manufacturing Operations (Cell and Gene Therapy)
- Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
- Develop and maintain compliant Quality processes to support GMP activities
- Provide QA support for GMP investigations/associated CAPAs, change controls, and risk assessments
- Track performance metrics and report to Quality Leadership team; develop tactics to improve performance outcomes
- Participate in inspection readiness activities and provide support for Quality development discussions as necessary during site inspections
- Enable team to achieve team goals/objectives and enable their individual career development.
Associate Director, Manufacturing Compliance Engineers
Sanofi
04.2022 - 06.2023
- Lead and engage a team of 11 people to ensure on time closure for deviations, CAPAs and change control requests and overall Quality Management System (QMS)
- Drive cross functional alignment for deviation, CAPA and process improvements
- Collaborate with cross functional teams for on time deviation closure, CAPA and CCR implementation and to manage timelines for lot shipment and release
- Successfully executed a reorganization of the team to increase headcount based on projections for the year and to optimize employee development and engagement
- Increased FTE headcount from 5 to 11 from Mar 2022 to present
- Created weekly QMS dashboard for Senior Leadership Team
- Implemented new ways of working to optimize efficiency and align with cross functional teams
- Organize and track the progress of QMS for two product work streams
- Currently on the Thyrogen leadership team - role includes partnering with Manufacturing, Quality, Facilities/Utilities, Automation and Quality Control to determine resolution of production, supply and quality issues
- Formerly a member of the Vaccine Autonomous Production Unit (APU) Leadership team and project Operation Warp Speed for approved EU Covid-19 Vaccine
- APU team oversaw operations, ensured successful Manufacturing and lot shipment/release for patient supply (product no longer active)
- Facilitated and managed large and complex projects such as Covid-19 and variant implementation, and execution of complex change controls
- SME for CAPAs, change control requests, and deviations for internal and external audits.
Supervisor, Manufacturing Specialist Supervisor
Sanofi
12.2020 - 04.2022
- Managed a team of 5 Manufacturing Specialists whose responsibilities include on time closure for deviations, CAPAs, change control requests, and continuous improvement initiatives in addition to on time shipment and lot certification
- Managed multiple change controls through complete lifecycle for implementation and modifications to large scale manufacturing equipment and process (Upstream and Downstream) for new COVID-19 vaccine production.
Manufacturing Specialist III
Sanofi
11.2019 - 12.2020
- Lead for change control requests, CAPAs, and Manufacturing support for Framingham campus, which consists of five multiproducts
- Highly skilled in CAPAs and CCRs using Quality Systems, MES electronic batch record corrections, electronic work instruction (EWI) updates, SOP and MBR updates
- Team lead assisting junior specialists with troubleshooting and problem solving
- Excel in document revisions and document creation using computer validated system
- Proficient in deviation writing, root cause analysis, and CAPA plan development.
Manufacturing Systems Specialist
Enterprise System Partners
10.2018 - 10.2019
- Part of Accenture Industry X.O - Framingham, MA
- MES Configuration using two platforms: Werum PAS-X Version 3.1.8, and Siemens SIMATIC IT EBR Version 6.1.5
- Electronic Batch Record (EBR) Development and Validation: configuration testing, documentation and validation of electronic batch records for Manufacturing operations.
Manufacturing Specialist I
Sanofi Genzyme
11.2015 - 10.2018
- Direct Support for Manufacturing operations: self inspections, audit assistance, submission of corrective work orders for equipment repairs, visual inspections, investigations for deviations, revision of PM job plans, and processing purchase orders
- Highly experienced with electronic batch record corrections (EBRs) utilizing Manufacturing Executing System (MES)
- Successfully achieved creation of buffer EBRs from paper records as an effort for a Transformation Project to upgrade and update facility for increased product output
- Managed and actively involved in problem solving for CCRs, CAPAs, continuous improvement projects to maximize operations
- Created Job Risk Assessments for Manufacturing operations
- Facilitated weekly review meetings for EBR corrections and coordinated deviation triage
- Coordinated rolling shutdown for 74 New York Ave Manufacturing Department.
Manufacturing Technician, Sr.
Sanofi Genzyme
04.2013 - 11.2015
- Experience with Microfiltration Skid for clarification of harvest material, membrane and skid cleanings
- Perform Chromatography to produce intermediate products and prepare for downstream operations
- Responsible for buffer preparation and transfers used for production operations
- Experience running production and clean in place (CIP) recipes using Emerson DeltaV
- Executed preventative maintenance, work orders, and engineering protocols
- Work transversally with Facilities, Quality Control, Quality Assurance, Validation, and Metrology
- Follow standard operating procedures (SOP) to execute operations and adhere to cGMP guidelines and ensure the suites are audit ready.
Manufacturing Associate II
Nitto Denko Avecia Inc.
01.2012 - 04.2013
- Lead purification projects for various types of oligonucleotide manufactures
- Responsible for opening production batches and accurately recording all materials using Oracle inventory software
- Responsible for communicating with the project team to ensure timely and accurate completion of batches under cGMP guidelines
- Revised quality documents such as CAPAs, SOPs, and Process Instructions using Pilgrim documentation program
- Maintained GMP integrity for Manufacturing suites
- Trained new operators on proper manufacturing procedures.
Manufacturing Associate I
Nitto Denko Avecia Inc.
07.2011 - 01.2012
- Accountable for Manufacturing processes from preparation steps to completion of manufacture, and assisted in execution of engineering protocols
- Routine operation, cleaning, and troubleshooting of Manufacturing equipment.
Education
Bachelor of Science - Biological Sciences
University of Vermont
Burlington, VTSkills
- Leadership
- Communication
- Problem Solving
- Strategy
- Effectively manage project timelines
- Resolutions for Quality Issues
- Collaboration
- Quality Management Systems
Certification
- Siemens EBR Functional Training, Framingham, MA, 02/2019
- Fundamentals of Bioprocessing for Engineers Course, Worcester, MA, 07/2016
Timeline
Director, GMP Operational Quality
Vertex Pharmaceuticals
08.2024 - Current
Associate Director, GMP Operational Quality
Vertex Pharmaceuticals
06.2023 - 08.2024
Associate Director, Manufacturing Compliance Engineers
Sanofi
04.2022 - 06.2023
Supervisor, Manufacturing Specialist Supervisor
Sanofi
12.2020 - 04.2022
Manufacturing Specialist III
Sanofi
11.2019 - 12.2020
Manufacturing Systems Specialist
Enterprise System Partners
10.2018 - 10.2019
Manufacturing Specialist I
Sanofi Genzyme
11.2015 - 10.2018
Manufacturing Technician, Sr.
Sanofi Genzyme
04.2013 - 11.2015
Manufacturing Associate II
Nitto Denko Avecia Inc.
01.2012 - 04.2013
Manufacturing Associate I
Nitto Denko Avecia Inc.
07.2011 - 01.2012
Bachelor of Science - Biological Sciences
University of Vermont
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