Frank Bianco

Frank Bianco Email and Phone Number

Vice President, Quality and Regulatory Compliance @ Molekule
san francisco, california, united states
Frank Bianco's Location
Alamo, California, United States, United States
Frank Bianco's Contact Details

Frank Bianco work email

Frank Bianco personal email

n/a
About Frank Bianco

Three products 510k cleared and counting!!!A goal-setting and achieving individual with 20 years of quality related experience in the inspection and compliance field. Proven leader accomplished through effective communication and accountability. To uphold the highest standards of safety and efficacy in products that transform lives, while fostering a solutions-oriented culture within my compliance teams.

Frank Bianco's Current Company Details
Molekule

Molekule

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Vice President, Quality and Regulatory Compliance
san francisco, california, united states
Website:
molekule.com
Employees:
146
Frank Bianco Work Experience Details
  • Molekule
    Vice President, Quality And Regulatory Compliance
    Molekule Aug 2023 - Present
    San Francisco Bay Area
    Management Representative responsible for direct oversight of Quality,Regulatory, and Environmental Health & Safety functionalareas. Ensure Molekule products and facilities are compliant with ISO 13485/MDSAP and FDA QSR. Develop, implement, and deliver submissions forMolekule's international regulatory strategy. Successful 510k clearances.
    View
  • Molekule
    Director, Quality And Regulatory Compliance
    Molekule Jul 2019 - Aug 2023
    San Francisco Bay Area
    Responsible for creating, implementing and auditing the necessary quality system procedures to ensure Molekule products and facilities are compliant with regulatory requirements including ISO 13485 and FDA QSR requirements. Develop, implement and deliver submissions for Molekule's international regulatory strategy.
    View
  • Roche
    Manager, Quality Systems
    Roche Mar 2017 - Jun 2019
    Pleasanton, Ca
    Responsible for the management of the Post-Market Surveillance, Vigilance, Nonconformance and CAPA programs for Roche Sequencing Solutions.
    View
  • Roche
    Principal Quality Specialist
    Roche Nov 2015 - Mar 2017
    Pleasanton, Ca
    Responsible for the development, implementation and admistration of the Post Market Surveillance/Vigilance, CAPA and Inspection Management programs for the new Roche Sequencing Unit.
    View
  • Genentech
    Qa Specialist Iii
    Genentech Nov 2013 - Nov 2015
    South San Francisco, Ca
    Support the site in preparing for, executing, and responding to Regulatory Inspections, Partner Inspections, and Audits. Manage difficult and sensitive issues that impact multiple functions, using cGMP regulations and Genentech/Roche standards.
    View
  • Fda
    Investigator
    Fda 2009 - Nov 2013
    Alameda, Ca
    Uphold and maintain the authoutrities and responsibilities granted in the Food Drug and Cosmetic Act (FD&C). Inspect and Investigate FDA regulated firms (food and medical device manufacturers) as a Lead Investigator. Level I Investigator certified.
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  • Alameda County Sheriff'S Office
    Criminalist Iii
    Alameda County Sheriff'S Office 2003 - 2009
    San Leandro, Ca
    Senior Criminalist performing the more complex technical work on evidence in the laboratory with review and evaluation of laboratory findings.
    View

Frank Bianco Skills

Computer Forensics Private Investigations Evidence Enforcement Criminal Investigations Investigation Government Policy Criminal Justice Criminal Law Homeland Security Fraud Policy Analysis Emergency Management Police Expert Witness Internal Investigations Surveillance Interrogation Firearms Law Enforcement Fda Capa Life Sciences Validation Quality Assurance Gmp Quality System Laboratory Biotechnology Corrective And Preventive Action Biopharmaceuticals Laboratory Skills Standard Operating Procedure Good Laboratory Practice U.s. Food And Drug Administration Pharmaceutical Industry Medical Devices Management

Frank Bianco Education Details

Frequently Asked Questions about Frank Bianco

What company does Frank Bianco work for?

Frank Bianco works for Molekule

What is Frank Bianco's role at the current company?

Frank Bianco's current role is Vice President, Quality and Regulatory Compliance.

What is Frank Bianco's email address?

Frank Bianco's email address is fr****@****ule.com

What schools did Frank Bianco attend?

Frank Bianco attended University Of Massachusetts Amherst, University Of New Haven, University Of San Francisco.

What are some of Frank Bianco's interests?

Frank Bianco has interest in Science And Technology, Children, Economic Empowerment, Health.

What skills is Frank Bianco known for?

Frank Bianco has skills like Computer Forensics, Private Investigations, Evidence, Enforcement, Criminal Investigations, Investigation, Government, Policy, Criminal Justice, Criminal Law, Homeland Security, Fraud.

Who are Frank Bianco's colleagues?

Frank Bianco's colleagues are Kirsty Boyd, Shawn Ford, Sommer Leavens, Regina Toney, Rory Bruggeman, Melanie Atterman, John Marks.

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