Marie London
Summary
Quality Assurance Leader with 12+ years of experience in GMP and GCP environments, specializing in QA oversight for gene and cell therapy clinical programs. Proven success supporting IND/BLA/MAA submissions, managing quality systems, and aligning expectations as products transition to commercial phase. Broad experience partnering with operations, technology, quality control, and other functions to drive QMS improvements across the organization. Adept at interpreting FDA/EMA/ICH guidance and aligning quality operations with evolving regulatory requirements. Passionate about continuous improvement, training development, and data integrity.
Overview
14
14
years of professional experience
Work History
Manager, Clinical Quality Assurance
Rocket Pharmaceuticals
03.2024 - Current
- Leads and manages QMS aspects related to the Clinical organization such as developing and implementing QMS metrics, document management, deviation and quality event review, CAPA oversight, and project tracking, working with functions within the organization, and providing administrative support of the eQMS.
- Established and manages cross-functional Clinical Process Oversight Committee to ensure required procedures are enacted in a timely manner. Committee identified 30+ procedural requirements to be rolled out over a six-month period and tracked progress as part of the meeting standard work.
- Supports IND, BLA, and MAA submissions and leads quality participation during regulatory inspections, serving as a key representative.
- Executes inspection readiness initiatives, including coordination, participation, and follow-up for internal audits.
- Direct and organizes all corrective actions related to regulatory inspections, reporting metrics to executive leadership.
- Authors and reviews clinical procedures to ensure regulatory compliance and clarity.
- Oversees and manages training for the Clinical Organization, including complete curricula development and deployment of over 40 employees.
- Conducts gap assessments on new regulatory guidance, including ICH E6(R3), and drives implementation plans.
- Delivers QA assessments and strategic input on organization decisions affecting training, QMS workflows, and compliance infrastructure.
- Leads and facilitates review of regulatory responses to Health Authority Information Requests.
- Co-leads auditing of third party vendors for the clinical organization.
- Performs Quality Control review of critical documents to ensure data integrity and patient safety.
Senior Manager, Quality Systems
Rocket Pharmaceuticals
11.2022 - 03.2024
- Tracked and reported all deviations, change controls, CAPAs, environmental monitoring reports, and invalid assays weekly to ensure timely closure.
- Served as administrator for eQMS – including system design, troubleshooting, query management, process improvement updates, and deployment and validation of workflows within the system (training, document management, audit module, issues, CAPAs, change controls, etc.)
- Compiled and presented site-wide Quality System Metrics for Management Review meetings.
- Directed QA oversight for the Data Governance program, ensuring data integrity and compliance.
- Mapped and managed projects for key Quality Management business initiatives.
- Designed training materials for QMS process improvements and delivered training across the organization.
- Updated and maintained core QMS procedures to reflect evolving standards.
- Led QMS readiness and served as point-of-contact during internal and external audits and inspections, including oversight of inspection responses related to QMS.
- Supervised the Document Control and Data Integrity teams, driving performance, improvements, and compliance.
- Managed direct reports through schedule and project management, one-on-ones, performance goal drafting, and career development planning.
- Championed continuous process improvements within the QA organization.
- Conducted regulatory gap assessments with cross-functional teams in response to regulations.
- Contributed to IND, BLA, and MAA submissions by reviewing and ensuring data quality.
- Reviewed and approved Master Batch Records, SOPs, Work Instructions, Forms, Protocols.
- Investigated and led resolution of major QMS Deviations, CAPAs, and Change Controls.
Senior Quality Assurance Analyst
Rocket Pharmaceuticals
10.2021 - 11.2022
- Lead quality assurance support for onsite manufacturing involving:
- Reviewing and approving Master Batch Records, SOPs, Work Instructions, Forms, and Protocols.
- Evaluation and approval of Deviations, CAPAs, Out of Specifications, and Change Controls.
- Reviewing and approving completed GMP batch documentation and assay data.
- Assessing and approving batch disposition decisions to ensure product quality.
- Delivering training on Good Documentation Practices and Data Integrity.
- Developed and implemented tracking metrics for SOP development to support GMP readiness. Coordinated with multiple departments to ensure the timelines were met and all required procedures were in place to support the initiation of in-house GMP manufacturing.
- Partnered with manufacturing related teams (operations, engineering, technology, etc.) to significantly improve on-time completion measures (from approximately 25% to over 75% in a six-month period).
- Manage the quality aspects of the facility Tier process, including tracking deviations, change controls, CAPA, EM reports and lab investigations.
- Reviewed, approved, and facilitated validation and qualification processes.
- Developed the master batch record procedures and supported the rollout at the facility, including reviewing production records, identifying/improving document design and development of production batch record workflow.
- Incorporated continuous improvement into standard work by incorporating small steady changes to drive significant business impact (as demonstrated by the on-time performance enhancements achieved over a six-month period).
- Scheduled and led one-on-one meetings, facilitated goal setting, and provided peer management support.
- Supported document control functions to maintain compliance and workflow efficiency.
Quality Assurance Supervisor
Patheon, Part of Thermo Fisher Scientific
04.2021 - 10.2021
- Management of performance and development of direct reports.
- Oversight of raw material release program.
- Reviewed and approved method qualifications for Cell Therapy specific assays.
- Reviewed and Approved Deviations, CAPAs, Out of Specifications, and Change Controls.
- Reviewed, approved, and dispositioned completed batch records and Quality Control assay data for early Phase Cell Therapy Manufacturing, ensuring accuracy and compliance.
- Managed Vendor Qualification System to ensure proper qualifications of contract vendors, including establishment of quality agreements, questionnaires, and remote audits.
- Led start-up and implementation of a new facility and Quality Management Systems for early phase Cell Therapy Manufacturing, first of its kind at Thermo Fisher Scientific.
- Acted as primary QA lead and liaison for facility build-out.
- Drafted and negotiated Quality Agreements with vendors.
- Created, reviewed, and approved SOPs, forms, work instructions, QC test methods, validation protocols for Cell Therapy Manufacturing.
- Participated in customer audits by presenting QA practices and supporting inspection readiness.
Quality Specialist II
Patheon, Part of Thermo Fisher Scientific
04.2019 - 04.2021
- Led scheduling and coordination of stability studies for drug substances and drug products, in accordance with cGLP.
- Led deviation investigations, identifying root causes, and recommending corrective actions.
- Performed routine chemical testing on raw materials, drug substances, drug products, and stability samples using analytical techniques including HPLC, ELISA, UV, FTIR, IEF, SDS-PAGE, CE, protein concentration, pH, conductivity, TOC, appearance, and density.
- Sampled and tested raw materials in accordance with USP and EP standards.
- Conducted sampling, aliquoting, and stability testing.
- Developed, validated, authored, and revised test methods to support laboratory operations.
- Performed quarterly internal audits to assess compliance and identify areas for improvement.
Staff Scientist I, Downstream Clinical Supply
Patheon, Part of Thermo Fisher Scientific
02.2012 - 01.2014
- Purified proteins for the manufacture of biopharmaceutical products under cGMP.
- Led downstream production projects, coordinating timelines and resources for manufacturing.
- Authored, revised, and maintained SOPs and Batch Records to support operations.
- Packed chromatography columns ranging in size from 60 cm to 2 cm for purification.
- Trained colleagues in aseptic techniques and executed sterile processes.
- Developed and optimized purification methods using UNICORN software.
Education
Bachelor of Science - Biology with a Concentration in Molecular Cell Physiology
Monmouth University
West Long Branch, NJ05.2011
Master of Legal Studies - concentration in Pharmaceutical Law
Seton Hall University
Newark, NJ01.2026
Skills
- CGMP and GCP Compliance (ICH, FDA, EMA)
- Inspection Readiness
- Risk Management
- Internal and External Auditing
- Program Management
- Cross-functional collaboration and communication
- Time management
- Adaptability in high-pressure environment
- Change management
- Team leadership
- Complex problem-solving
- Staff training and development
Publications
- Palladino, M.A., London, Marie, et al., Effects of lipopolysaccharide-induced inflammation on hypoxia and inflammatory gene expression pathways of the rat testis. Basic and Clinical Andrology (2018 28:14) https://bacandrology.biomedcentral.com/articles/10.1186/s12610-018-0079-x
- Palladino, M.A., Karpodinis (London), Marie, et al., Myeloid cell leukemia-1 (Mcl-1) is a candidate target gene of hypoxia-inducible factor-1 (HIF-1) in the testis. Reprod. Biol. Endocrinol., 10:104, 2012. DOI: 10.1186/1477-7827-10-104. http://www.rbej.com/content/10/1/104
Timeline
Manager, Clinical Quality Assurance
Rocket Pharmaceuticals
03.2024 - Current
Senior Manager, Quality Systems
Rocket Pharmaceuticals
11.2022 - 03.2024
Senior Quality Assurance Analyst
Rocket Pharmaceuticals
10.2021 - 11.2022
Quality Assurance Supervisor
Patheon, Part of Thermo Fisher Scientific
04.2021 - 10.2021
Quality Specialist II
Patheon, Part of Thermo Fisher Scientific
04.2019 - 04.2021
Staff Scientist I, Downstream Clinical Supply
Patheon, Part of Thermo Fisher Scientific
02.2012 - 01.2014
Master of Legal Studies - concentration in Pharmaceutical Law
Seton Hall University
Bachelor of Science - Biology with a Concentration in Molecular Cell Physiology
Monmouth University