Nicole Hartley
Johnston,RI
Summary
Results-driven quality professional with more than 25 years of experience in regulated 21 CFR-compliant cGMP and clinical pharmaceutical/biotech settings. Demonstrated success in Quality Systems, QA Validation, Compliance, Quality Control, Microbiology, and Raw Materials management. Advanced proficiency in Veeva, TrackWise, Zen QMS, Dot Compliance, ComplianceWire, Change Management, inspection readiness, and Quality System oversight.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Director Quality Systems
Dyne Therapeutics
Waltham, MA
01.2024 - Current
- Lead oversight and governance of document control operations within Veeva eDMS, ensuring data integrity, compliance, and lifecycle management effectiveness.
- Directed vendor management program, including qualification, performance evaluation, risk assessment, and ongoing compliance oversight of GxP vendors.
- Managed enterprise training program through compliance wire, overseeing onboarding/offboarding processes role based curricula, and inspection readiness training compliance.
- Developed, implemented, and continuously improved quality system processes including Change Management, CAPA, Deviations, Investigations, Product Quality Complaints and Management Review.
- Established quality metrics, tracked and trended system performance data, and delivered executive-level reporting to support informed decision making.
- Designed and delivered organization wide Quality Systems training to strengthen compliance culture and procedural adherence
Associate Director Quality Systems
Dyne Therapeutics
Waltham, MA
11.2022 - 01.2024
- Develop and maintain Quality processes and systems including change control, CAPA, deviations, investigations, label control, laboratory control, product quality complaints and management review.
- Track, trend and analyze quality system data and information including summarizing findings for management.
- Develop and provide quality system training across the organization
- Participate in inspection readiness activities and internal/external audits and inspections
Senior Manager Quality Assurance Validation
RUBIUS THERAPEUTICS
Smithfield, RI
04.2022 - 11.2022
- Lead and manage the QA Validation Team, providing proactive leadership with strong interpersonal and communication skills to ensure team performance and compliance objectives are met.
- Extensive experience in Pharmaceutical and Biotech industries, with versatile expertise spanning project management, Quality Assurance, qualifications, and validation of facilities, utilities, and equipment.
- Review, approve, and oversee all validation deliverables, including Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Risk Assessments, and Protocols (IQ, OQ, PQ) related to:
Aseptic process validation
Computer System Validation (CSV)
Technology transfers, method transfers, and method/process changes
Equipment implementation and modifications - Provide QA oversight for asset management activities within the Computerized Maintenance Management System (CMMS/BMRAM), ensuring compliance and operational reliability.
- Partner with cross-functional teams to drive compliance, risk mitigation, and inspection readiness across validation programs.
Senior Manager Quality Systems
RUBIUS THERAPEUTICS
Smithfield, RI
01.2020 - 04.2022
- Developed, implemented, and managed monthly Site Quality Council initiatives, driving cross-functional engagement and continuous improvement.
- Established and maintained site KPIs to monitor Quality Council effectiveness, increase awareness, and measure improvements across quality systems.
- Led key project to configure Veeva for compliant management of Deviations and CAPA during COVID-19, avoiding the need for additional QMS module purchases.
- Supported Quality Management Review (QMR) reporting by providing metrics, data analysis, and authoring sections of the report for senior leadership.
- Contributed to site-wide risk management activities, including maintenance and updates to the site Risk Register to ensure proactive compliance and mitigation strategies.
Manager Quality Systems
RUBIUS THERAPEUTICS
Smithfield, RI
01.2019 - 01.2020
- Led enterprise implementation and validation of Veeva eDMS; served as System Administrator with full lifecycle governance, ensuring data integrity and 21 CFR Part 11 compliance.
- Selected, validated, and deployed ComplianceWire LMS; established governance structure and served as System Administrator.
- Designed and built the company-wide Training Program, including curricula development, OJT frameworks, and instructor-led GMP training to ensure sustained inspection readiness.
- Established and governed core QMS processes, including Change Control, Deviation Management, and CAPA programs.
- Developed and implemented controlled systems for Batch Record Issuance, Form Issuance, and Logbook Management to strengthen documentation compliance.
- Designed and implemented the archival strategy and records retention program aligned with regulatory requirements.
- Developed and delivered Annual GMP Training to all employees, reinforcing quality culture and compliance standards.
- Provided leadership oversight for Quality Systems, Documentation Control, and Training functions.
- Established the Quality Risk Management Program, including Root Cause Analysis (RCA) tools and risk mitigation frameworks.
- Directed the Vendor Management Program, including qualification, performance monitoring, and compliance oversight of GxP vendors.
Senior Manager Quality Systems
KERYX/AKEBIA BIOPHARMACEUTICALS
Boston, MA
01.2018 - 01.2019
- Serve as System Owner and Administrator for Veeva eDMS and ComplianceWire, managing user access, creating and assigning training curricula, and overseeing document lifecycle management. Responsible for developing and maintaining the site-wide training program.
- Create and manage the Audit Master Schedule; conduct internal and external audits to ensure cGMP compliance and readiness for regulatory inspections.
- Manage the Product Complaint System from intake to closure, including documentation, investigation oversight, root cause evaluation, CAPA approval, and authoring of closure letters.
- Design, implement, and deliver annual cGMP training across the site to reinforce compliance and quality culture.
- Oversee Deviation, CAPA, and Change Control systems, including monitoring and reporting of quality metrics to support continuous improvement.
- Lead site Inspection Readiness activities and serve as the backroom lead during regulatory inspections.
- Implement and manage the Vendor Management Program, ensuring qualification, ongoing performance evaluation, and compliance oversight.
- Coordinate, draft, and finalize the Annual Product Quality Review (APQR) for the site.
- Lead and author the Quarterly Management Review (QMR) Process, reporting quality metrics and trends to senior leadership.
Manager Quality Assurance
Keryx/Akebia
Boston, MA
01.2018 - 07.2018
- Manage, develop and maintain quality, policies, processes, procedures and controls as they pertain to GMPs for drug product including GMP manufacturing and testing services at contract manufacturing organizations (CMOs), and testing services
- Maintains effective communication and builds relationships with internal and external contractors, vendors and partners
- Support manufacturing and quality operations by assisting with the review, approval and maintenance of documentation, including protocols, procedures, from contract organizations
- Working with Contract Manufacturing Organizations (CMO) ensuring that all vendors remain in a state of compliance to regulatory expectations
- Additional responsibilities will include assisting in or leading Investigation activities, Corrective and Preventive Action activities, Change Control activities and providing general quality assurance support for the overall Quality System
- Product Disposition for Drug Substance and Drug Product
- Tracking and reporting metrics as required by FDA Guidance
- Auditing both internal and external
Quality Assurance Systems Specialist IV
ALEXION PHARMACEUTICALS, INC.
Smithfield, RI
09.2013 - 12.2017
- Served as System Owner and Site Lead for Change Control, managing the full lifecycle from initiation through review and approval, ensuring compliance with cGMP and regulatory requirements.
- Proficient in CAPA, Deviation, and Effectiveness Check processes, providing oversight and guidance to ensure timely and effective resolution.
- Provided lot disposition analysis and quality system reporting to support the release of Bulk Drug Substance.
- Partnered with change owners to develop risk assessments required for Change Control, integrating quality risk management principles.
- Managed and facilitated Change Control Review Board meetings both locally and globally, ensuring alignment with corporate and regulatory standards.
- Delivered TrackWise training and maintained electronic system access for site personnel on Change Control, CAPA, and Deviation processes.
- Certified Kepner-Tregoe Process Facilitator/Coach, skilled in Situation Appraisal, Decision Analysis, and Problem Analysis to support structured problem-solving.
- Supported internal audits for compliance with 21 CFR and ICH guidelines; acted as Backroom Lead during regulatory agency inspections.
- Authored chapters and provided data for the Annual Product Quality Review (APQR) and represented Quality Systems during Quarterly Metrics Review (QMR).
Quality Control Analyst IV
ALEXION PHARMACEUTICALS, INC.
Smithfield, RI
01.2009 - 09.2013
- Acted as Subject Matter Expert (SME) for the Raw Material Program during Health Authority inspections, supporting audit and regulatory compliance activities.
- Performed internal audits and supported external agency inspections to ensure adherence to cGMP and FDA requirements.
- Initiated and managed Change Controls, OOS investigations, CAPA, Deviations, and Environmental Excursions from inception to closure.
- Trained laboratory analysts on USP methods, ensuring technical proficiency and consistent application of test procedures.
- Reviewed raw test data and released raw materials in SAP, maintaining data integrity and regulatory compliance.
- Oversaw worldwide storage of Master and Working Cell Banks, ensuring proper handling, tracking, and documentation.
- Developed and validated test methods in alignment with FDA and cGMP requirements to support the testing and release of raw materials for FDA-approved products.
Quality Control Analyst III
ALEXION PHARMACEUTICALS, INC.
Smithfield, RI
03.2007 - 01.2009
- Led the startup of a new laboratory, including acquisition of equipment, drafting and implementing SOPs, and preparing for validation and qualification activities.
- Conducted testing and release of compendial and excipient raw materials per USP and EP standards using a variety of analytical methods, including assays (manual and Titroprocessor), Karl Fischer, FTIR, identification (ID), loss on drying, heavy metals, melting point, and other relevant USP General Chapter tests.
- Facilitated Raw Materials Committee meetings, providing technical insights and supporting material release decisions.
- Led area tours and readiness activities for internal regulatory inspections, ensuring laboratory compliance and adherence to cGMP standards.
Senior Laboratory Analyst
NORTH SAFETY PRODUCTS
Cranston, RI
01.2005 - 01.2007
- Performed confirmatory tests on raw materials per USP/NF, ANSI and ASTM.
- Collaborated with the new product development team testing prototypes for future product launches.
- Performed testing on raw materials and finished product per USP/NF, ANSI and ASTM using FTIR, UV/Vis, TOC analyzer and other general laboratory equipment
- Calibrated and maintained test equipment in accordance to ISO 9000, cGMP protocols
- Performed microbiological assays including monitoring the purified water system and testing for the presence or absence of objectionable organisms as it relates to the release of final product
- Bioburden testing
- Implemented and maintained environmental monitoring program
Quality Control Analyst III
DOW BIOPHARMACEUTICAL CONTRACT MANUFACTURING SERVICES
Smithfield, RI
09.2003 - 09.2004
- Responsible for troubleshooting problems that arise with assays and project timelines
- SDS-PAGE and Western Blot analysis
- Sampling, inspection, and USP/NF/ACS monograph testing of raw material components under cGMP guidelines employing aseptic techniques
- Prepared reagents and test solutions necessary to perform assays per USP/NF and ACS
Quality Control Analyst III
DOW BIOPHARMACEUTICAL CONTRACT MANUFACTURING SERVICES
Smithfield, RI
08.2001 - 09.2003
- Created Raw Material Reagent data base itemizing all reagents and test solutions necessary to perform compendial testing to facilitate the efficient testing and release of materials
- Authored and revised specifications and SOP’s in accordance with the current compendial literature
- Devised training modules for USP General Chapter testing including training other analysts.
- Proficient in conducting laboratory investigations and preparing incident reports
- Responsible for the implementation of new laboratory equipment including initiating the process for calibration, validation, origination of the SOP’s, in addition to training other analysts
- Performed routine tests including TOC, Conductivity and pH
Quality Assurance Specialist
NORTH SAFETY PRODUCTS
Cranston, RI
01.1999 - 08.2001
- Performs internal compliance Audits in accordance with ISO 9001, cGMP and FDA guidelines
- Maintained Product Complaint System from inception to close by performing root cause analysis and corrective action utilizing the CPAR system when necessary
- Member of the Material Review Board (MRB)
Senior Laboratory Technician
NORTH SAFETY PRODUCTS
Cranston, RI
10.1995 - 01.1999
- Performed tests on raw materials and finished product per USP/NF, ANSI and ASTM using FTIR, UV/Vis, TOC analyzer and other general laboratory equipment
- Ability to write detailed test procedures and SOP’s, which describe the experimental operations necessary to test routine samples and R&D projects
- Calibrated and maintained test equipment in accordance with ISO 9000, cGMP protocols
Education
Master of Science - Biotechnology, Regulatory Affairs
Johns Hopkins University
BSED - Education
Rhode Island College
Providence, RIBachelor of Arts - Biology, Chemistry
Rhode Island College
Providence, RIAssociates Degree - Science
Community College of Rhode Island
Skills
- Quality Systems Leadership & Governance
- Deviation, Change Control & CAPA Oversight
- Risk Management & Quality Risk Assessments
- Regulatory Compliance (FDA & 21 CFR)
- Inspection Readiness Strategy & Execution
- Health Authority Inspection Management
- Audit Management
- Quality Metrics, Trending & Executive Reporting
- QMS Optimization & Continuous Improvement
- Training Program Development & Compliance Oversight
- TrackWise, Veeva & ComplianceWire System Administration
- Cross-Functional Team Leadership & Mentorship
Accomplishments
Certifications
Lead Investigator Qualification Training, Kepner Tregoe, 2013
Problem Solving and Decision-Making Training, Kepner Tregoe, 2014
IVT’s Quality Risk Management 2015
Certified Veeva Vault Platform Business Administrator, Veeva 2021
Advanced Management Leadership Training, RI Bio 2022
WCS Auditing and Qualifying Suppliers and Vendors 2023
American Society for Quality
CQT - Certified Quality Technician
CQA - Certified Quality Auditor – 2001 certification current
Rhode Island Department of Education
Certified Teacher General Science, Biology (High School with Middle School Endorsement)
Certification
- Certified Teacher General Science, Biology (High School with Middle School Endorsement)
- Lead Investigator Qualification Training, Kepner Tregoe, 2013
- Problem Solving and Decision-Making Training, Kepner Tregoe, 2014
- IVT’s Quality Risk Management 2015
- Certified Veeva Vault Platform Business Administrator, Veeva 2021
- Advanced Management Leadership Training, RI Bio 2022
- WCS Auditing and Qualifying Suppliers and Vendors 2023
- CQT - Certified Quality Technician
- CQA - Certified Quality Auditor – 2001 certification current
Timeline
Director Quality Systems
Dyne Therapeutics
01.2024 - Current
Associate Director Quality Systems
Dyne Therapeutics
11.2022 - 01.2024
Senior Manager Quality Assurance Validation
RUBIUS THERAPEUTICS
04.2022 - 11.2022
Senior Manager Quality Systems
RUBIUS THERAPEUTICS
01.2020 - 04.2022
Manager Quality Systems
RUBIUS THERAPEUTICS
01.2019 - 01.2020
Senior Manager Quality Systems
KERYX/AKEBIA BIOPHARMACEUTICALS
01.2018 - 01.2019
Manager Quality Assurance
Keryx/Akebia
01.2018 - 07.2018
Quality Assurance Systems Specialist IV
ALEXION PHARMACEUTICALS, INC.
09.2013 - 12.2017
Quality Control Analyst IV
ALEXION PHARMACEUTICALS, INC.
01.2009 - 09.2013
Quality Control Analyst III
ALEXION PHARMACEUTICALS, INC.
03.2007 - 01.2009
Senior Laboratory Analyst
NORTH SAFETY PRODUCTS
01.2005 - 01.2007
Quality Control Analyst III
DOW BIOPHARMACEUTICAL CONTRACT MANUFACTURING SERVICES
09.2003 - 09.2004
Quality Control Analyst III
DOW BIOPHARMACEUTICAL CONTRACT MANUFACTURING SERVICES
08.2001 - 09.2003
Quality Assurance Specialist
NORTH SAFETY PRODUCTS
01.1999 - 08.2001
Senior Laboratory Technician
NORTH SAFETY PRODUCTS
10.1995 - 01.1999
Associates Degree - Science
Community College of Rhode Island
Master of Science - Biotechnology, Regulatory Affairs
Johns Hopkins University
BSED - Education
Rhode Island College
Bachelor of Arts - Biology, Chemistry
Rhode Island College