Roberta Johnson

Roberta Johnson Email and Phone Number

GxP Quality Development/Deployment/Management @ IDEAYA Biosciences
Roberta Johnson's Location
Oceanside, California, United States, United States
Roberta Johnson's Contact Details

Roberta Johnson work email

Roberta Johnson personal email

n/a
About Roberta Johnson

Proven success managing and improving quality, compliance, training, and document control practices in fast-paced medical environments. Highly skilled at developing and implementing regulatory strategies and processes to gain product approvals worldwide. A leader of people, projects, and overall alignment with core business objectives.Areas of Expertise:  Quality Management  Continuous Improvement Corrective/Preventive Action Root Cause Analysis Organizational Training/GxP Training Programs Business Process Mapping Scorecard development, Tracking and Reporting Policy/Procedure Development Supplier Management Internal/External Compliance Audits Safety/Regulatory Compliance Program and Project Management  Global Regulations including US, EU, JP and ROW regulations in relation to GMP, GCP, GLP, GDP and PV regulations for pharmaceuticals/drugs/biologics/in vitro diagnostics/medical devices ISO Standards (9001, 13485, 14971, 17025, ISO 14001)Industry Designations: Certified Quality Manager/Operation Excellence, American Society for Quality (ASQ) Certified Lead Auditor for 13485, Stat-A-Matrix Certified Biomedical Auditor, American Society for Quality Certified Quality Auditor, American Society for QualityTechnical Skills:Adobe Acrobat | MS Office | MS Project | MS Visio | SharePoint | MasterControl | QMS Systems | Track WiseDocumentum | Alchemy | Livelink | FirstDoc | Veeva | SAP/ERP | Blue Mountain

Roberta Johnson's Current Company Details
IDEAYA Biosciences

Ideaya Biosciences

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GxP Quality Development/Deployment/Management
Roberta Johnson Work Experience Details
  • Ideaya Biosciences
    Director Of Quality
    Ideaya Biosciences Sep 2021 - Present
    South San Francisco, California, Us
    View
  • Soleno Therapeutics, Inc.
    Director, Quality Systems
    Soleno Therapeutics, Inc. Nov 2020 - Sep 2021
    Redwood City, California, Us
    View
  • Intercept Pharmaceuticals
    Associate Director, Quality Systems
    Intercept Pharmaceuticals Sep 2017 - Oct 2020
    Morristown, New Jersey, Us
    View
  • Intercept Pharmaceuticals
    Associate Director, Quality Systems Via Beacon Hill (Consultant)
    Intercept Pharmaceuticals Jul 2017 - Sep 2017
    Morristown, New Jersey, Us
    View
  • Biogenesis Consulting Inc.
    Chief Quality Officer
    Biogenesis Consulting Inc. Jun 2016 - Jun 2017
    Developed and implemented Quality Compliance programs to ensure conformity with regulatory agencies and all applicable standards worldwide. Provided counsel, training, auditing and interpretation of FDA and other regulatory requirements to client project teams.
  • Alexion Pharmaceuticals, Inc.
    Manager, Corporate Quality & Compliance – Audits And Inspection Readiness
    Alexion Pharmaceuticals, Inc. Feb 2016 - Apr 2017
    Boston, Massachusetts, Us
    Planned, scheduled and conducted audits of worldwide operations to ensure compliance with global GxP standards and regulations.
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  • Smith & Nephew Biotherapeutics
    Manager, Quality Assurance Audits
    Smith & Nephew Biotherapeutics Jan 2014 - Feb 2016
    Watford, Hertfordshire, Gb
    Executed global GxP audit programs based on defined plans and procedures, CAPA processes, and specific time constraints domestically and internationally. Researched current corporate and governmental expectations, enforcements, new regulations and standards. Developed and provided QA training for Inspection Readiness and revised/new audit processes.
    View
  • Meso Scale Discovery
    Manager, Quality Audits
    Meso Scale Discovery Sep 2011 - Jan 2014
    Rockville, Maryland, Us
    Served as key contributor to the company ISO-certified Quality Management System. Served as the Deputy Management Representative during ISO audits, ISO Steering Committee Meetings and Management Review processes. Developed revised/new audit processes.
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  • Meso Scale Discovery
    Lead Internal Auditor
    Meso Scale Discovery Jun 2011 - Sep 2011
    Rockville, Maryland, Us
    View
  • Qiagen (Formerly Digene)
    Quality Specialist Iii
    Qiagen (Formerly Digene) Jan 2008 - Jun 2011
    Venlo, Limburg, Nl
    View
  • Digene Corporation (Currently Qiagen)
    Quality Systems Specialist Ii
    Digene Corporation (Currently Qiagen) Feb 2006 - Jan 2008
    Us
    View
  • Wellstat Therapeutics
    Quality Systems Document Specialist
    Wellstat Therapeutics Jan 2005 - Feb 2006
  • Medifacts
    Quality Assurance Coordinator
    Medifacts Nov 2003 - Jan 2005
  • Otsuka
    Senior Document Coordinator
    Otsuka May 2001 - Nov 2003
    Princeton, Nj, Us
    View

Roberta Johnson Skills

Fda Gmp Quality Assurance Capa Quality System Biotechnology Quality Auditing Validation Iso 13485 Glp Medical Devices Iso Pharmaceutical Industry 21 Cfr Part 11 U.s. Food And Drug Administration Gcp Sop Change Control Computer System Validation Software Documentation Life Sciences Supplier Quality Standard Operating Procedure V&v Document Management Gxp Technology Transfer Quality Control Trackwise Continuous Improvement Regulatory Affairs Good Laboratory Practice Internal Audit Clinical Trials Iso Standards Design Control Cgmp Hardware Diagnostics Biopharmaceuticals Clinical Development Supplier Quality Management Sop Development Cro Laboratory Diagnostics Lifesciences Iso 14971 R Fda Gmp Vaccines

Roberta Johnson Education Details

  • The George Washington University School Of Medicine And Health Sciences
    The George Washington University School Of Medicine And Health Sciences
    Health Sciences
  • Trinity Washington University
    Trinity Washington University
    Business Administration

Frequently Asked Questions about Roberta Johnson

What company does Roberta Johnson work for?

Roberta Johnson works for Ideaya Biosciences

What is Roberta Johnson's role at the current company?

Roberta Johnson's current role is GxP Quality Development/Deployment/Management.

What is Roberta Johnson's email address?

Roberta Johnson's email address is rj****@****rma.com

What schools did Roberta Johnson attend?

Roberta Johnson attended The George Washington University School Of Medicine And Health Sciences, Trinity Washington University.

What are some of Roberta Johnson's interests?

Roberta Johnson has interest in Quality, Children, Social Services, Civil Rights And Social Action, Education, Learning To Paint, Environment, Continuous Improvement, Poverty Alleviation, Gourmet Cooking.

What skills is Roberta Johnson known for?

Roberta Johnson has skills like Fda, Gmp, Quality Assurance, Capa, Quality System, Biotechnology, Quality Auditing, Validation, Iso 13485, Glp, Medical Devices, Iso.

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