Patricia Hebert
Southborough,MA
Summary
Encouraging, collaborative Quality manager and analytical problem-solver with talents for team building, leading and motivating, as well as excellent customer relations aptitude and relationship-building skills. Proficient in using independent decision-making skills and sound judgment to positively impact company success and the quality culture needed to cost effectively meet compliance directives. Dedicated to applying training, monitoring and morale-building abilities to enhance employee engagement and boost performance.
Overview
25
25
years of professional experience
Work History
SENIOR DIRECTOR, DIGITAL COMPLIANCE
AlloVir
09.2023 - 01.2024
- Drive deep collaboration and implement remediation and continuous improvement with global program teams and key product development and commercial partners, including CMC Technical Services, Supply Chain, IT and Regulatory Affairs.
- Establish policies and procedures for computerized system design, qualification, validation, and data integrity
- Partner with Functional Areas, GxP System Owners and IT to shape direction for computerized GxP solutions
- Establish department key performance indicators in alignment with company and operational goals, as well as maintain and report department and delivery metrics
- Lead inspection readiness projects and support regulatory body inspections to positive outcome
- Recruit and develop team to execute department responsibilities, ensuring effective use of resources through strong leadership, including consistent performance management, robust employee development and routine rewards and recognitions practices
- Support Quality Risk Management culture while proactively identifying, assessing and mitigating quality, operational and organizational risks, with appropriate escalation of key risks and issues
- Identified compliance gaps and designed compliant data practices with external partners (CMO & CTO)
- Drafted CSA/CSV program adaptable to on-premises, SaaS and custom software solutions
- Contributed to URS for custom proprietary software used in distribution of drug product
- Provided compliance oversight and testing guidance to Veeva Business / IT owners.
DIRECTOR, CSA/CSV, QAV AND DATA INTEGRITY
Seres Therapeutics
09.2021 - 09.2023
- Partnering with IT, led team of CSV and DI professionals in support of Seres business and compliance goals, assuring compliant, validated implementation of Veeva QMS and critical operational systems, achieving audit readiness
- Represented quality unit as interface with Operations and IT for design, deployment, enhancement, and management of GxP systems and development of IT operating policies and procedures with special attention to change management
- Represented IT and Operations for Digital Compliance during regulatory audits
- Grew high performing team comprised of FTEs and consultants to achieve goals for DI, CSV and QAV while supporting growth and compliance goals necessary for market approval and support of first of kind drug product
- Strengthened internal controls by reviewing existing policies and procedures, ensuring compliance with regulatory requirements.
- Defined, led and completed audit and remediation project for all IT solutions - enterprise and laboratory - in preparation for first commercial product launch
- Through close collaboration and partnership with IT and Operations, achieved inspection readiness resulting in no 483 observations for IT, data integrity, or CSV
- Audited and mentored European CMO assuring audit readiness and resulting in no 483 observations for IT, data integrity, or CSV
- Closely collaborated with SaaS vendors (e.g Veeva, Benchling, Blue Mountain) to ensure sustainable 'right-sized', risk based solutions.
- Established regression test plans for all SaaS platforms to support automatic updates
- Established compliant, right-sized IT change management for Veeva Docs and Veeva QMS
- Participated on cross functional team to establish Azure storage solution and Veeva eTMF to successfully migrate 7 clinical studies from multiple CROs
- Led the CSV team to plan and implement the Benchling LIMS solution enterprise wide (Donor Centers, Donor Test Lab, R&D, Manufacturing Operations) while remediating LabWare LIMS in the laboratory.
DIRECTOR, DIGITAL COMPLIANCE
Sanofi
09.2018 - 09.2021
- Managed 8 professionals directly, and served as Program Lead to team comprised of 2 project managers and up to 25 SMEs for phased LabWare LIMS implementation
- Supported establishment of short and long-range operational and quality plans and strategic IT objectives related to Operations and QMS
- Led team to develop and conduct GxP training programs, inspection readiness programs, internal/external audit programs with focus on digital compliance
- Led teams to establish and execute digital compliance strategies to remediate compliance gaps and establish continuous improvement mindset
- Collaborated with operations, IT and quality staff to assure robust deviation investigations and effective CAPA
- Provided internal and external (CMO/SaaS) audit support, ensuring consistent application of standards and regulations related to GMP Operations with focus on IT and Data Integrity, and Digital Compliance
- Provided guidance and led cross functional teams to implement IT and quality strategies with respect to collection, documentation, analysis, problem solving, and reporting of Key Performance Indicators (KPIs)
- Provided guidance and expertise to Risk Management team, ensuring risks to QMS were properly and consistently characterized for IT systems, and escalated to senior leadership in timely manner
- Program Owner for LIMS, led high performing, cross functional implementation and validation team and established/implemented strategic direction for ongoing life cycle management
- Accountable for on time and in budget program management
- Established highly effective Digital Compliance team empowered to voice their ideas and communicate openly with each other and customers.
- Achieved successful audit readiness for Digital program, resulting in no 483 observations, including for implementation of fully digital, multi-product biologics manufacturing facility
- Led Global Biologics Division through development and implementation of harmonized Data Integrity programs throughout Biologics, always staying within budget and completing work on time
- Successfully led LIMS implementation including design and validation, and instrument integration, for multi-product site with no subsequent compliance findings.
ASSOCIATE DIRECTOR, QUALITY SYSTEMS & DIGITAL COMPLIANCE
Sanofi Genzyme
09.2016 - 09.2018
- Established quality system to achieve and sustain digital compliance while subscribing to robust SDLC methodologies
- Partnered with IT to establish and deliver Data Integrity Training throughout the site, prioritizing system owners and project management professionals. Training was then delivered internationally, throughout Biologics
- Provided leadership and support to global Biologics sites (France, Germany, Belgium) in the establishment and implementation of Data Integrity remediation programs at multiple facilities worldwide
- Remediated laboratory and manufacturing digital systems ensuring full data integrity
- Partnered with the QC validation team to establish form-based validation for laboratory equipment and software to efficiently leverage vendor provided documentation while focusing in-house testing effort on intended use (CSA)
- Supported regulatory audits throughout global Biologics, including a sustained, long-term presence in Europe
- Provided budget and resource management oversight to complete projects on time and in budget.
PRINCIPAL QUALITY ENGINEER
Sanofi Genzyme
12.2014 - 09.2016
- Provided QA governance and guidance for technical operations in QC Laboratory, Laboratory Technical Services (method development) and IT with focus on new method transfer, system implementation, and equipment validation
- Gap assessed Analyzer, Manufacturing systems, and Software solutions for Data Integrity and Part 11 compliance, establishing and leading remediation effort spanning operations throughout Framingham facility.
SENIOR IT COMPLIANCE CONSULTANT
Aztec Consulting
05.2012 - 12.2014
- Assure compliance to IT and site procedures, and mentor staff in the completion of Quality Records and System Qualification/Validation
- Mentored staff to author compliant, focused, action driven procedures that align to corporate directives and standards, and QMS objectives - emphasis on SDLC, Infrastructure and IT Change Management
- Represented Manufacturing Systems and IT on the deviation review board, and all matters related to the QMS, including support during quality system audits
- Provided leadership to deviation investigation teams and participated with cross functional teams to identify purposeful, metric driven improvements (CAPA)
- Established validation strategies and related life cycle documentation in support of digital initiatives
- Authored validation plans, IQ/OQ/PQ and supporting documentation for manufacturing and quality control systems, environmental monitoring, and quality systems (documentation, QMS)
- Collaborated across manufacturing, quality control, and facilities to author EMS user requirements.
COMPLIANCE PROJECT MANAGER, LEAD
Globiox
10.2010 - 05.2012
- Led project teams to overcome deviation investigation backlogs, often in companies under consent decree
- Led client cross functional teams and consulting teams to remediate Part 11 compliance gaps, often under time and resource constraints, and within FDA/EMA commitment requirements
- Authored validation plans and IQ/OQ/PQ and related SDLC documentation
- Performed compliance investigations: manufacturing operations, automated processes, analytical laboratory, and stability programs
- Provided training and mentored client staff to implement process / procedure per QMS content and objectives (GLP and GMP)
- Designed and utilized risk mitigation tools (FMEA, Process Mapping) to establish risk-based approach to QMS implementation.
PROJECT MANAGER (MEDICAL DEVICE/DIAGNOSTICS)
Luminex
06.2005 - 09.2010
- Provided project management and cGMP expertise, including design controls, design transfer, and product and process validation, for a newly formed assay development organization
- Established an outsourcing model for assay development and validation on a proprietary medical device
- Led internal R&D project team in the development of mRNA assays and establishment of batch records/procedures for subsequent kit manufacture
- Established development and validation methodologies to support compliance with leading regulatory agencies (FDA/EMA), as well as ISO guidelines
- Supported cross functional teams in the establishment of CE marks, package inserts, labeling claims for diagnostic assay kits.
PROJECT MANAGER (MEDICAL DEVICE/DIAGNOSTICS)
Pharmaceutical Service Company
06.2004 - 06.2005
- As a Quality Systems SME for validation, deviation investigations and change control, provided consulting services to pharmaceutical/biotech accounts
- Performed quality system audits and deviation investigations, process, equipment and computer system validation.
- Provided Project Management for FDA-regulated clients specializing in the implementation of software and equipment to support Quality System requirements -delivered exceptional customer satisfaction, by proactively addressing client concerns and meeting or exceeding expectations throughout the engagement process.
- Authored the Validation Plan to relocate and establish two medical device manufacturing operations that were merging into one new facility after a business merger
- Validated and Implemented a new QMS software solution (Trackwise) in support of the merger of two medical device companies.
TECHNICAL SERVICES ADMINISTRATOR
Blood and Tissue Center of Central Texas
09.2001 - 06.2004
- Managed 30-35 technical and operations staff (testing, component manufacturing, inventory and delivery) to ensure compliant and reliable availability of safe blood and tissue products in the Central Texas region
- Updated testing and reporting platforms, introducing automation
- Successfully defended practices with FDA and CAP throughout my tenure.
QUALITY ASSURANCE MANAGER
SeraCare Technology
03.1999 - 09.2001
- SeraCare in Austin was a plasma testing laboratory owned by Griffols
- Primary duties included cGMP training, QA batch review, validation, and deviation investigations
- Accomplishments included leading and validating a new and significantly larger cGMP laboratory with no observations from FDA.
LABORATORY ANALYST
SeraCare Technology
09.1998 - 03.1999
- Seton Medical Center, Austin, TX / Dec 1997 - Sep 1998 St
- Joseph Hospital, North Providence, RI / Sep 1995 - Dec 1997
- Laboratory generalist performed clinical tests in hematology, blood bank, chemistry, microbiology and serology
- Performed phlebotomy duties ensuring patient safety
- Evaluated quality control within laboratory using standard laboratory test and measurement controls
- Successfully testified in RI court to defend testing practices in a DUI case, changing and improving state precedents.
Education
BS Clinical Science -
UNIVERSITY OF RHODE ISLAND
Kingston, RISkills
- Collaborative Leadership
- Culture Transformation
- Team Building/Motivation
- Policy Development: GMP, EMA - Part 11/Annex 11, GAMP 5, CFR Title 21, EudraLex Volume 4
- Maintaining Compliance - Digital SME
- Project & Budget Management
- Contract and Vendor Management, Supplier Auditing
- People Management, Staff Development
- Operations Management
- Project/Program Leadership & Coordination
- Risk Assessment, Gap Remediation
- Audit Strategies/Management
Timeline
SENIOR DIRECTOR, DIGITAL COMPLIANCE
AlloVir
09.2023 - 01.2024
DIRECTOR, CSA/CSV, QAV AND DATA INTEGRITY
Seres Therapeutics
09.2021 - 09.2023
DIRECTOR, DIGITAL COMPLIANCE
Sanofi
09.2018 - 09.2021
ASSOCIATE DIRECTOR, QUALITY SYSTEMS & DIGITAL COMPLIANCE
Sanofi Genzyme
09.2016 - 09.2018
PRINCIPAL QUALITY ENGINEER
Sanofi Genzyme
12.2014 - 09.2016
SENIOR IT COMPLIANCE CONSULTANT
Aztec Consulting
05.2012 - 12.2014
COMPLIANCE PROJECT MANAGER, LEAD
Globiox
10.2010 - 05.2012
PROJECT MANAGER (MEDICAL DEVICE/DIAGNOSTICS)
Luminex
06.2005 - 09.2010
PROJECT MANAGER (MEDICAL DEVICE/DIAGNOSTICS)
Pharmaceutical Service Company
06.2004 - 06.2005
TECHNICAL SERVICES ADMINISTRATOR
Blood and Tissue Center of Central Texas
09.2001 - 06.2004
QUALITY ASSURANCE MANAGER
SeraCare Technology
03.1999 - 09.2001
LABORATORY ANALYST
SeraCare Technology
09.1998 - 03.1999
BS Clinical Science -
UNIVERSITY OF RHODE ISLAND
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