Gwen Fisher

Gwen Fisher Email and Phone Number

Quality & Regulatory Compliance Leader | Pharma & Medical Device @ iRhythm Technologies, Inc.
Orange County, California, United States
Gwen Fisher's Location
Laguna Hills, California, United States, United States
Gwen Fisher's Contact Details

Gwen Fisher personal email

n/a
About Gwen Fisher

Dynamic quality leader with 20+ years of cGxP experience in FDA regulations, ICH requirements, and ISO standards for pharmaceutical and medical device industries. Proven success developing and leading diverse global quality teams and implementing global quality management systems (QMS). Supported worldwide product transfer projects and commercial product launches. Led successful FDA pharmaceutical pre-approval inspections (PIA), routine inspections, and hosted successful notified body medical device technical documentation audits and certification audits.

Gwen Fisher's Current Company Details
iRhythm Technologies, Inc.

Irhythm Technologies, Inc.

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Quality & Regulatory Compliance Leader | Pharma & Medical Device
Orange County, California, United States
Website:
irhythmtech.com
Employees:
1682
Gwen Fisher Work Experience Details
  • Irhythm Technologies, Inc.
    Irhythm Technologies, Inc.
    Orange County, California, United States
    View
  • Spyglass Pharma, Inc.
    Senior Director, Quality
    Spyglass Pharma, Inc. Aug 2023 - Aug 2024
    Aliso Viejo, California, Us
    View
  • Advanced Sterilization Products (Asp)
    Director, Global Quality Systems
    Advanced Sterilization Products (Asp) 2018 - May 2023
    Irvine, Ca, Us
    • Strategized and established global quality system team (~25 FTE) to support global registrations, operations, and distribution due to company acquisition• Developed, validated, and implemented global QMS for complaints and regulatory reporting, quality events (CAPA, nonconformance, field action/recall), change control, document control, training• Headed quality management reviews and safety review boards• Led inspection readiness and hosted successful notified body audits
    View
  • Johnson & Johnson
    Sr. Manager, Product Quality (Advance Sterilization Products, Inc.)
    Johnson & Johnson 2017 - 2018
    New Brunswick, Nj, Us
    • Managed sustaining quality engineers for capital medical devices• Led global product lifecycle continuous improvements projects• Supported product design changes and technical transfers• Monitored and evaluated post market surveillance data and reporting• Reviewed and approved product risk files per ISO 14971
    View
  • Johnson & Johnson
    Sr. Manager, Regulatory Compliance (J&J Regulatory Compliance)
    Johnson & Johnson 2013 - 2017
    New Brunswick, Nj, Us
    • Managed internal auditors, internal audit program, and inspection readiness for multiple J&J MedTech sites• Implemented continuous improvement actions to improve internal audit metrics• Led regulatory inspection backrooms with multiple workstreams• Supported FDA responses and action plans to successfully lift of an FDA Warning Letter at ASP
    View
  • Teva Parenteral Medicines, Inc.
    Manager, Quality Control
    Teva Parenteral Medicines, Inc. 2011 - 2012
    •Managed chemists, technical writers, and stability coordinator •Remediated commercial stability program to ensure on-time data analysis and reporting•Implemented laboratory instrument qualification program to support continuous improvement and cost reduction efforts
  • Teva Parenteral Medicines, Inc.
    Manager, Supplier Quality
    Teva Parenteral Medicines, Inc. 2008 - 2011
    • Managed supplier quality program and associates• Strategized and implemented supplier management and monitoring process for CMO and CDMO• Conducted supplier audits (qualification, surveillance, for cause)• Composed and negotiated supplier quality agreements
  • Teva Parenteral Medicines, Inc.
    Supervisor, Regulatory Compliance
    Teva Parenteral Medicines, Inc. 2006 - May 2008
  • Teva Parenteral Medicines, Inc.
    Auditor, Regulatory Compliance
    Teva Parenteral Medicines, Inc. 2003 - 2006
  • Sicor Pharmaceuticals, Inc.
    Chemist, Quality Control
    Sicor Pharmaceuticals, Inc. 1999 - 2003

Gwen Fisher Skills

Gmp Fda Quality System Capa Change Control Pharmaceutical Industry Quality Assurance Validation Aseptic Processing V&v Sop Lims

Gwen Fisher Education Details

  • Heidelberg University
    Heidelberg University
    Environmental Biology And Business Administration

Frequently Asked Questions about Gwen Fisher

What company does Gwen Fisher work for?

Gwen Fisher works for Irhythm Technologies, Inc.

What is Gwen Fisher's role at the current company?

Gwen Fisher's current role is Quality & Regulatory Compliance Leader | Pharma & Medical Device.

What is Gwen Fisher's email address?

Gwen Fisher's email address is gw****@****cox.net

What schools did Gwen Fisher attend?

Gwen Fisher attended Heidelberg University.

What skills is Gwen Fisher known for?

Gwen Fisher has skills like Gmp, Fda, Quality System, Capa, Change Control, Pharmaceutical Industry, Quality Assurance, Validation, Aseptic Processing, V&v, Sop, Lims.

Who are Gwen Fisher's colleagues?

Gwen Fisher's colleagues are Carlos Saldana, Melissa Page, Msn, Rn, Ne-Bc, Kimberly Mcmahan Cpc, Cpma, Nanci Correa, Steve Morgan, Maiysha Bell, Taylor Mcdaniel, Cct.

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