Mike Malafronte

Mike Malafronte Email and Phone Number

VP, Quality @ Impel Pharmaceuticals
Kirkland, WA, US
Mike Malafronte's Location
Greater Seattle Area, United States, United States
Mike Malafronte's Contact Details

Mike Malafronte personal email

n/a
About Mike Malafronte

A Quality Leader with over 25 years of experience in biopharmaceuticals and medical device's focusing on Quality Assurance and Quality Systems. That experience includes instituting quality systems in start-ups, virtual companies and multinational corporations.Key specialties include: Quality Assurance, Quality Systems, cGMP, GCP, GLP, Regulatory Compliance, Compliance Audits, Manufacturing Quality Agreements, FDA Inspection Facilitation, Strategic Business Planning, Workforce Planning and Budgeting.

Mike Malafronte's Current Company Details
Impel Pharmaceuticals

Impel Pharmaceuticals

View
VP, Quality
Kirkland, WA, US
Mike Malafronte Work Experience Details
  • Impel Pharmaceuticals
    Vp, Quality
    Impel Pharmaceuticals
    Kirkland, Wa, Us
  • Impel Pharmaceuticals
    Vp, Quality
    Impel Pharmaceuticals Feb 2017 - Present
    Seattle, Washington, Us
  • Blaze Bioscience
    Head Of Quality
    Blaze Bioscience Feb 2016 - Jan 2017
    Responsible for Quality Management for drug development.
  • Impel Pharmaceuticals
    Director, Quality
    Impel Pharmaceuticals 2015 - 2016
    Seattle, Washington, Us
    Responsible for all aspects of Quality for drug-device combination clinical and commercial products.
  • Nitto Denko Technical
    Senior Director
    Nitto Denko Technical 2013 - 2015
    Responsible for all GXP activities in the pre-clinical and development phases of clinical trials.
  • Theravance
    Director, Quality Operations
    Theravance 2011 - 2012
    South San Francisco, Ca, Us
    Directed team members within Quality Assurance and provide leadership in CMC teams for molecules in clinical development.
  • Quorum Review Irb
    Director, Quality Management And Document Administration
    Quorum Review Irb 2008 - 2011
    Seattle, Wa, Us
    Directed the operations of the Quality Management Team and Document Administration teams totaling 65 employees.
  • Nastech Pharmaceutical
    Senior Director, Quality Assurance
    Nastech Pharmaceutical 2002 - 2008
    Us
    Directed the operations of the Quality Assurance groups located in Bothell, WA and Hauppauge, NY, facilities with total headcount of 11 employees.
  • Icos
    Associate Director, Qa
    Icos 1993 - 2002
    Us
    Directed the Quality Assurance group of five managers and 22 employees.
  • Abbott Laboratories
    Manager, Document Control
    Abbott Laboratories 1989 - 1993
    Abbott Park, Illinois, Us
    Developed Document Control system and transferred documentation to other Abbott manufacturing facilities.
  • Abbott Laboratories
    Document Control Administrator
    Abbott Laboratories 1989 - 1993
    Abbott Park, Illinois, Us
  • Alcon Labs
    New Product Development Coordinator
    Alcon Labs 1984 - 1989

Mike Malafronte Skills

Fda Gmp Quality Control Sop Quality Assurance Regulatory Affairs Quality System Capa Quality Management V&v Regulatory Submissions Drug Development Clinical Development Software Documentation Program Management Clinical Research Contract Manufacturing Change Management Commercialization 21 Cfr Part 11 Manufacturing

Mike Malafronte Education Details

  • University Of Washington
    University Of Washington
    Kinesiology And Exercise Science
  • University Of Rhode Island
    University Of Rhode Island
    Accounting And Business/Management

Frequently Asked Questions about Mike Malafronte

What company does Mike Malafronte work for?

Mike Malafronte works for Impel Pharmaceuticals

What is Mike Malafronte's role at the current company?

Mike Malafronte's current role is VP, Quality.

What is Mike Malafronte's email address?

Mike Malafronte's email address is ma****@****ast.net

What schools did Mike Malafronte attend?

Mike Malafronte attended University Of Washington, University Of Rhode Island.

What skills is Mike Malafronte known for?

Mike Malafronte has skills like Fda, Gmp, Quality Control, Sop, Quality Assurance, Regulatory Affairs, Quality System, Capa, Quality Management, V&v, Regulatory Submissions, Drug Development.

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