Stephen Shields

Stephen Shields Email and Phone Number

Computerized System Compliance Consultant at Shape Therapeutics, Inc. @ Shape Therapeutics, Inc.
Stephen Shields's Location
Greater Tampa Bay Area, United States, United States
Stephen Shields's Contact Details

Stephen Shields work email

Stephen Shields personal email

n/a
About Stephen Shields

• Successful Quality Assurance corporate leadership track record in compliance and validation. • Strong background in developing compliance programs and staff• Results driven to resolve business, product, and information technology concerns and issues• Solution driven to positively impact bottom-line results and streamline processes• World class expertise in equipment and computerized system validation and compliance• Excellent record in passing regulatory inspections• Industry expertise in US, EU, Canadian, Brazilian, Japanese and other GxP regulations for Pharmaceutical, Biological, Medical Device, and combination products

Stephen Shields's Current Company Details
Shape Therapeutics, Inc.

Shape Therapeutics, Inc.

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Computerized System Compliance Consultant at Shape Therapeutics, Inc.
Stephen Shields Work Experience Details
  • Shape Therapeutics, Inc.
    Computerized System Compliance Consultant
    Shape Therapeutics, Inc. Oct 2019 - Present
    Seattle, Washington, Us
    Develop computerized systems compliance Quality Management System for startup (policies, SOPs & templates). Audit Software as a Service suppliers.
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  • Pbs Biotech, Inc.
    Senior Consultant
    Pbs Biotech, Inc. Feb 2019 - Present
    Camarillo, California, Us
    Performed gap assessment to identify potential compliance issues for Software Development Quality Management System and regulatory compliance of Vertical-Wheel Technology product's computerized systems. Provided recommendations to correct findings. Continuing to provide guidance for improvements and assess improvement activities.
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  • Pegatron
    Senior Auditor
    Pegatron Nov 2019 - Nov 2019
    Taipei, Tw
    Performed pre-PMTA inspection audit of the Juul manufacturing line to identify potential compliance issues for computerized systems and electronic data integrity. Provided recommendations to improve deficiencies.
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  • Pharma Tech Industries, Inc.
    Senior Auditor
    Pharma Tech Industries, Inc. Aug 2019 - Sep 2019
    Royston, Georgia, Us
    Performed audit to identify potential compliance issues for computerized systems’ quality management system, computerized systems validations, and electronic data integrity. Provided recommendations to correct findings.
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  • Thai Kyowa Kako Co., Ltd
    Senior Auditor
    Thai Kyowa Kako Co., Ltd Feb 2019 - Apr 2019
    Performed pre-FDA inspection audit of the Thai Kyowa manufacturing site to identify potential compliance issues for computerized systems and electronic data integrity. Provided recommendations and action item list to correct findings.
  • Immunomedics
    Csc Senior Auditor
    Immunomedics Nov 2018 - Dec 2018
    Morris Plains, New Jersey, Us
    Performed post PAI inspection audit of the Immunomedics site to identify potential compliance issues for computerized systems and electronic data integrity. Provided recommendations and action item list to correct findings. Developed and provided detailed assessment template for evaluating a computerized system’s compliance to US and EU regulations and validation best practice.
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  • Shanghai Kyowa Amino Acid, Inc
    Csc Senior Auditor
    Shanghai Kyowa Amino Acid, Inc Oct 2018 - Nov 2018
    Performed pre-FDA inspection audit of the SKAA manufacturing site to identify potential compliance issues for computerized systems and electronic data integrity. Provided recommendations and action item list to correct findings.
  • Becton Dickinson
    Csv Senior Consultant
    Becton Dickinson Feb 2018 - May 2018
    Franklin Lakes, New Jersey, Us
    Established and managed remediation activities to resolve FDA Warning Letter findings related to computerized laboratory systems. Established system inventory list and performed compliance and data integrity gap assessments on systems. Recommended QMS, computer system, and data integrity improvements to meet US and EU regulations.
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  • Juno Therapeutics, Inc.
    Compliance Auditor
    Juno Therapeutics, Inc. Nov 2017 - Jan 2018
    Seattle, Wa, Us
    Performed Quality Systems and data center audits of hosting and IT infrastructure services provided by Secure-24. Recommended improvements to Secure-24 and Juno Therapeutics QMSs
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  • Adma Biologics, Inc.
    It Quality Compliance Consultant
    Adma Biologics, Inc. Jun 2017 - Sep 2017
    Ramsey, Nj, Us
    Provided tools for assessing computerized system compliance and electronic data integrity. Performed assessments and determined remediation and mitigation activities for IT infrastructure, laboratory, manufacturing, and quality systems. Authored policies, standards, SOPs, and templates. Performed related training.
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  • Validant
    Senior Consultant
    Validant Apr 2016 - Nov 2016
    San Francisco, Ca, Us
    Bend Research, Inc. Head of IT Quality AssuranceAssessing Quality Management System for computerized system compliance and data integrity. Strategize quality improvements. Creating/Revising SOPs and validation templates. Providing QA oversight for major validation projects (network re-qualification, SCADA infrastructure, Empower 3 custom field calculations, SAP)
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  • Quality Compliance Partners, Inc.
    Senior Consultant
    Quality Compliance Partners, Inc. Sep 2015 - Apr 2016
    San Diego, Ca, Us
    Illumina, Inc, Senior Validation ConsultantProviding consulting services for improvements in computerized system validation processes and support of the Pumice remediation project: validation planning, requirements generation, Part 11 assessments, risk assessments, test planning and test case development, test execution training, validation reports.
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  • Allergan
    Director, Worldwide Quality Assurance, Technology And Validations
    Allergan Aug 2014 - Jun 2015
    Dublin, Coolock, Ie
    Due to the ability to meet and exceed MBOs and implementing continuous improvements across the organization, staffing and accountabilities were expanded to include the corporate Quality Management System (QMS) for aseptic processing, sterilization, environmental monitoring and all validations (process, computerized systems, equipment, cleaning, filter...). Exhibited global leadership via: 1) maintaining world class WWQA standards, SOPs, guidances, and templates that met regulatory expectations; 2) Provided inspection readiness directions to sites based on evolving regulations and trends resulting in successful regulatory inspections; 3) Oversaw conformance of manufacturing sites and regional offices thru collaboration and influence; 4)Developed highly competent staff which was well respected throughout the organization; 5)Assessed compliance risks of new acquisitions/partners and corrected issues resulting in no findings during PAIs; 6) Provided body of knowledge worldwide base upon regulations, guidances, industry standards and guides (e.g. GAMP, ISO, PDA, ISPE, PIC/S, etc. best practices) resulting in improved site competence; 7) Key contributor in cross functional teams to determine and implement continuous improvements
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  • Allergan
    Director, Wwqa Computer System Compliance & Quality
    Allergan Feb 2008 - Aug 2014
    Dublin, Coolock, Ie
    Accountable for corporate quality management system (QMS) for GMP computerized system compliance and validation. Established WWQA standards for computerized system compliance. Assessed, developed plans, and implemented plans for resolving significant compliance issues for new acquisitions. Key contributor for continuous improvements in auditing, CAPA, deviations, and situational analysis. Proactively modified and communicated changes to QMS (e.g. revision of Annex 11, guidance changes to 21 CFR Part 11) resulting in successful regulatory inspections. Provided QA support for global GMP computerized system implementations. Audited manufacturing sites and IT suppliers. Implemented Quality Agreements between the manufacturing sites and IT organization.
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  • Allergan
    Senior Manager, Worldwide Quality Assurance, Computer System Validation
    Allergan Apr 2006 - Feb 2008
    Dublin, Coolock, Ie
    Developed and implemented global SOPs for computerized system compliance. Audited software vendors and Allergan manufacturing sites. Provided training and training materials for computer system validation and compliance, 21 CFR Part 11, good documentation practices, etc. Provided QA review for validations of Blue Mountain Calibration Manager/RAM, SAP apps, Empower, Labware LIMS, PaxPro, Trackwise QMS, DaCS spreadsheets, CoreDossier, SAS, Data Centers, Trackwise System Inventory…
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  • Genentech
    Csv Consultant
    Genentech Feb 2006 - Apr 2006
    South San Francisco, California, Us
    Wrote validation documents for the Plateau Training Management system and met all timelines. Received praise for the quality and conciseness of the documents.
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  • Elan Pharmaceuticals
    Associate Director, Qa - Systems Validation
    Elan Pharmaceuticals Dec 2004 - Dec 2005
    Dublin 2, Ie
    Support computerized system validations for GCP systems. Developed Quality validation guidelines and documentation for use within IT and other associated Elan departments. Conducted internal and vendor audits. Created training materials and performed training for Computer Validation methodology and Part 11 Compliance. Managed validations of Argus Safety System, Business Objects, Audit Reporting System, DS Navigator…
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  • Medimmune
    Senior Manager - Corporate Computer Validation
    Medimmune Dec 2002 - Dec 2004
    Gaithersburg, Maryland, Us
    Setup Corporate Computer Validation Department. Implemented validation methodology which resulted in robust systems being implemented within budget and having high level of user acceptance. Implemented risk assessment to establish appropriate level of validation. Managed validation budgets. Managed validation staff and consultants worldwide. Managed validations of SAP, Documentum, Sparta Trackwise, Core Dossier, OracleClinical, spreadsheets, Impact, SCADAs, Building Management System, ARISg Safety System, Maximo...
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  • Cardinal Health
    Senior Manager - Computer System Validation
    Cardinal Health Apr 2000 - Nov 2002
    Dublin, Oh, Us
    Designed and implemented one of the largest TotalChrom Client/Server Data Acquisition systems in the world. Managed validation of Labware LIMS system, Calibration Manager, various laboratory instruments. Collaborated with corporate QA staff to design global compliance program.
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  • Sas Institute
    Developer
    Sas Institute Jun 1998 - Apr 2000
    Cary, Nc, Us
    Performed code fixes for SAS Multi-Dimensional Database software using C.
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  • Eds Corporation
    Systems Engineer
    Eds Corporation 1997 - 1998
    Provided on-site technical support at North Carolina Wildlife Department. The EDS system was used for hunting and fishing licenses and boat tags.
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Stephen Shields Skills

Computer System Validation 21 Cfr Part 11 Validation Quality Assurance Gxp Gmp Pharmaceutical Industry Capa Fda Change Control V&v Pharmaceutics Biotechnology Medical Devices Glp Lims Gamp Quality System Regulatory Affairs Sop Life Sciences Cross Functional Team Leadership Csv Iso 14971 Trackwise Ctms Aseptic Processing Drug Development Technology Transfer Gcp Design Control Quality Control Chromatography Pharmacovigilance Fda Gmp R&d Biopharmaceuticals Regulatory Submissions Iso 13485 Quality Auditing Cro Annex 11 Data Integrity Regulatory Requirements Cleaning Validation Analytical Chemistry Lifesciences Vaccines Protocol Biologics

Stephen Shields Education Details

  • North Carolina State University
    North Carolina State University
    Computer Science
  • Texas A&M University
    Texas A&M University
    Chemistry
  • The University Of Texas At Arlington
    The University Of Texas At Arlington
    Chemistry

Frequently Asked Questions about Stephen Shields

What company does Stephen Shields work for?

Stephen Shields works for Shape Therapeutics, Inc.

What is Stephen Shields's role at the current company?

Stephen Shields's current role is Computerized System Compliance Consultant at Shape Therapeutics, Inc..

What is Stephen Shields's email address?

Stephen Shields's email address is sh****@****gan.com

What is Stephen Shields's direct phone number?

Stephen Shields's direct phone number is +171424*****

What schools did Stephen Shields attend?

Stephen Shields attended North Carolina State University, Texas A&m University, The University Of Texas At Arlington.

What skills is Stephen Shields known for?

Stephen Shields has skills like Computer System Validation, 21 Cfr Part 11, Validation, Quality Assurance, Gxp, Gmp, Pharmaceutical Industry, Capa, Fda, Change Control, V&v, Pharmaceutics.

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