Maria Brown

Maria Brown Email and Phone Number

Vice President Cell Therapy Development and Operations Quality at Bristol-Myers Squibb @ Bristol-Myers Squibb
Maria Brown's Location
New York City Metropolitan Area, United States, United States
Maria Brown's Contact Details
About Maria Brown

Quality management professional with expertise in global quality systems, manufacturing quality assurance, development quality assurance, external manufacturing quality assurance and GMP/GDP compliance. Experienced in pharmaceutical quality management, committed to adding value, fostering teamwork and delivering exceptional results.

Maria Brown's Current Company Details
Bristol-Myers Squibb

Bristol-Myers Squibb

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Vice President Cell Therapy Development and Operations Quality at Bristol-Myers Squibb
Maria Brown Work Experience Details
  • Bristol-Myers Squibb
    Vice President Cell Therapy Development And Operations Quality
    Bristol-Myers Squibb Nov 2019 - Present
    Lawrence Township, Nj, Us
    Head of Global Quality for Cell Therapy Development and Operations.
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  • Celgene
    Vice President Global Quality Systems And Compliance
    Celgene Jul 2018 - Nov 2019
    Summit, New Jersey, Us
    Responsible for Celgene’s Global GMP/GDP Quality Management System and Compliance processes across bio-pharmaceutical manufacturing, testing, development and logistics facilities. • Design and implement governance and compliance processes to ensure small molecule, biologic, cell therapy and other products, are in full compliance with all applicable GMP and GDP regulations, company quality policies and procedures. • Design and implement robust processes and systems for Product Complaints, Change Management, Deviation, CAPA, Training, Document Management, Laboratory Systems, Quality Risk Management, Quality Analytics, Quality Agreements, Recall, Management Review and other global quality systems and compliance processes. • Develop and implement global GMP/GDP compliance controls, processes and systems encompassing:• GMP/GDP policies, quality manual and standards; • Comprehensive training on GMP/GDP compliance; • Monitoring GMP/GDP compliance; • Global Quality Risk management program; • Global Data Integrity Program;• Responsible for the development, implementation and oversight of a risk based GMP/GDP audit program including establishment of applicable procedures, program administration, execution of audits of GMP/GDP contract service and material suppliers and monitoring effectiveness through KPIs. • Provide product quality leadership throughout the product lifecycle. Responsible for pre-approval inspection readiness for pipeline products.• Lead senior leadership engagement in compliance status and product quality metrics through Global Management Review.• Provide GMP/GDP oversight of health authority inspections. • Identify and ensure implementation of emerging and changing GMP/GDP regulations.
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  • Celgene
    Executive Director Global Quality Systems
    Celgene Sep 2012 - Jul 2018
    Summit, New Jersey, Us
    • Established and maintained global GMP/GDP policies, quality manual and procedures, ensuring consistent deployment throughout the organization; • Implemented and managed global documentation systems, processes and procedures;• Administered supplier GMP audit program and quality agreement processes and procedures;• Established and managed global GMP training processes and procedures • Implemented and managed global quality management systems, processes and procedures for product complaints, deviations; CAPA and change control • Developed and administered global compliance processes including management review, annual product quality review, quality agreements, health hazard evaluations, regulation change management, data integrity program, product recall processes and procedures; and quality risk management;• Product quality stewardship across product lifecycle; • Developed, designed and implemented global metrics and KPI systems and processes;• Implemented quality processes in ERP Quality Modules• Quality oversight of enterprise GMP IT systems and processes.
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  • Celgene
    Senior Director Corporate Quality
    Celgene Oct 2010 - Aug 2012
    Summit, New Jersey, Us
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  • Abraxis Bioscience
    Sr. Director Corporate Quality Assurance
    Abraxis Bioscience Apr 2010 - Aug 2010
    Los Angeles, Ca, Us
    Responsible for directing global Corporate Quality Assurance functions across pharmaceutical manufacturing and development facilities.• Corporate Compliance-Responsible for Supplier Qualification Program; Internal Audit Program; Complaint Management; Enterprise IT system QA oversight and regulation and compendia revision management.• Product Development (PD) Quality Assurance-Responsible for directing quality systems for product development functions and audit of development protocols, reports, stability data; managing record archives; approval of PD related SOP’s, specifications, test methods, certificate of analysis and protocols. • Pre-Clinical Quality Assurance- Responsible for directing quality systems for Pre-clinical/research GLP and CLIA laboratory and audit of protocols and reports for pre-clinical/research functions; management of record archives and SOP systems; approval of SOP’s, protocols and audit of contract test laboratories.• Global Quality Assurance-Responsible for directing quality interactions with global subsidiaries and partners; developing and maintaining quality systems and quality technical agreements with global partners and subsidiaries; maintaining site master files for global submission; managing change control process for entry into new global markets and changes in global regulations.• Corporate Quality Systems and Documentation-Responsible for establishing corporate policies and procedures; implementation of best quality practices; establishing corporate documentation systems.• Corporate Microbiology-Responsible for implementation of policies and procedures for microbiology methods and processes; providing microbiology oversight of operations, including aseptic processing, environmental monitoring, sterilization validation, aseptic processing qualification and filtration. • Training-Responsible for directing development of training curricula and programs; learning management system administration.
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  • Abraxis Bioscience
    Sr. Director Qa/Qc
    Abraxis Bioscience Nov 2007 - Mar 2010
    Los Angeles, Ca, Us
    Responsible for directing Global Quality Assurance and Quality Control functions across three facilities including parenteral aseptic manufacturing facilities and product development and quality control testing facility. •Directed the following quality management functions: Global compliance, manufacturing quality assurance, GMP Training, quality control, product development quality assurance, supplier quality, internal audit.•Implemented global quality systems resulting in successful product launches in Europe, Australia, China, India, Canada and Japan. •Developed supplier quality programs, including establishment of quality agreements, external audits and material qualifications.•Successfully implemented SAP as the business process owner for the SAP Quality Module. •Hosted successful FDA, EMEA and global partner audits. •Implemented quality systems, policies and Standard Operating Procedures (SOP).
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Maria Brown Skills

Gmp Capa Fda Pharmaceutical Industry Change Control Quality System Aseptic Processing Sop Quality Assurance Validation Standard Operating Procedure U.s. Food And Drug Administration Quality Control Corrective And Preventive Action Biotechnology Technology Transfer Trackwise Good Laboratory Practice Regulatory Affairs 21 Cfr Part 11 Quality Auditing Manufacturing Quality Assurance And Quality Control Product Development Quality Assurance Supplier Quality Management Global Health Authority Inspection Management Gmp Compliance And Training Gmp Change Control Product And Process Investigation Cleaning Validation Quality Management Gxp Verification And Validation Good Manufacturing Practice Quality Engineering Principles And Techniques Documentation Systems Contract Manufacturing Quality Management Root Cause Analysis Risk Management Erp System Implementation Sap And Oracle

Maria Brown Education Details

  • University Of Illinois Urbana-Champaign
    University Of Illinois Urbana-Champaign
    Microbiology
  • Southern Illinois University Edwardsville
    Southern Illinois University Edwardsville
    Master Of Business Administration (M.B.A.)

Frequently Asked Questions about Maria Brown

What company does Maria Brown work for?

Maria Brown works for Bristol-Myers Squibb

What is Maria Brown's role at the current company?

Maria Brown's current role is Vice President Cell Therapy Development and Operations Quality at Bristol-Myers Squibb.

What is Maria Brown's email address?

Maria Brown's email address is mh****@****ene.com

What is Maria Brown's direct phone number?

Maria Brown's direct phone number is +131088*****

What schools did Maria Brown attend?

Maria Brown attended University Of Illinois Urbana-Champaign, Southern Illinois University Edwardsville.

What skills is Maria Brown known for?

Maria Brown has skills like Gmp, Capa, Fda, Pharmaceutical Industry, Change Control, Quality System, Aseptic Processing, Sop, Quality Assurance, Validation, Standard Operating Procedure, U.s. Food And Drug Administration.

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