Vice President Of Quality
Current
May 2024 - Present
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Mike Roth Email & Phone Number
Strategic Global Quality & Compliance Exectutive | Pharmaceutical / Biotech Industry Excellence | Leading Clients to Optimize Growth | Consultant & ASQ Certified Qualified Auditor
at
Nurix Therapeutics
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✓ Verified May 2026
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Profile completeness 86%
Current company
Role
Strategic Global Quality & Compliance Exectutive | Pharmaceutical / Biotech Industry Excellence | Leading Clients to Optimize Growth | Consultant & ASQ Certified Qualified Auditor
Location
San Francisco Bay Area, United States, United States
Company size
Who is Mike Roth? Overview
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Quick answer
Mike Roth is listed as Strategic Global Quality & Compliance Exectutive | Pharmaceutical / Biotech Industry Excellence | Leading Clients to Optimize Growth | Consultant & ASQ Certified Qualified Auditor at Nurix Therapeutics, a company with 129 employees, based in San Francisco Bay Area, United States, United States. AeroLeads shows a matched LinkedIn profile for Mike Roth.
Mike Roth previously worked as Vice President of Quality at Nurix Therapeutics and Vice President Quality Assurance at Rain Oncology. Mike Roth holds Master'S Degree, Pharmacological Oncology from University At Buffalo.
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Nurix Therapeutics
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Profile bio
About Mike Roth
Proactive Senior Global Quality Leader driving the execution of Quality Assurance Operations and Compliance strategies from early stages to commercial scale manufacturing in both Biotech and Pharmaceutical companies. Proven track record in contributing to CMC regulatory submissions of INDs, IMPDs, CTAs, MAAs and NDAs facilitating successful registration and post-approval commercialization of products and product-candidates.Focused on key quality- strategic and operational matters that have significant, direction-setting impact while balancing regulatory/legal requirements, client needs, and pharma innovation. SME in parenteral and solid oral dosage manufacturing processes for peptides, small molecules, proteins and DNA. Extensive GMP/GLP/GCP and CAP/CLIA auditing experience for virtual companies. Exceptional cross-functional contributor, builder of numerous Quality organizations, and recognized award-winning industry expert.
Current workplace
Mike Roth's current company
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Nurix Therapeutics
10 roles · 26 years
Mike Roth work experience
A career timeline built from the work history available for this profile.
Vice President Quality Assurance
Led, coached and managed the Global Quality and Compliance group of 5 FTEs and 3 consultants for GXP activities. Developed Quality budgets. Managed the SOPs and Policies for Phase 3 activities. Supported DOE studies and risk-based assessments for API and DP. Supported the Commercial team on TPP development for planned commercial launches. Reviewed IND/IMPD.
Apr 2021 - Nov 2023
Vice President Quality Assurance
Principia Biopharma/ Sanofi
Directed the QA group of 5 FTEs on process validation plans for API and DP. Managed and reviewed the SOPs and Policies for commercial activities. Supported QMS development for commercial launch and due diligence activities. Supported clinical studies and nonclinical studies and GCP investigations. Reviewed technical quality agreements. Supported Veeva.
Apr 2020 - Apr 2021
Executive Director Of Quality Assurance
Managed the QA group of 3 FTEs and 2 consultants and a budget Coordinated IMPD submission with QP oncritical timelines. Conducted QMS audits and implemented Quality Agreements with over 12 CMOs.
Sep 2016 - Apr 2020
Director Of Quality Control And Assurance
Managed QA/QC staff of 9 FTEs and oversaw a budget. Provided Quality Management Reviews (QMRs) to uppermanagement. Led QA Audit Program and performance gap assessments of CMOs. Worked with manufacturingon process and cleaning validation.
Apr 2015 - Sep 2016
Senior Consultant
Led Quality audits per ISO 13485:2003, 23640:2011, EP25-A and 21 CFRs 11, 809 and 820. Revised SOPs and reviewed CAPAs for FDA readiness. Led war room for FDA inspectional activities. Worked with various staff to reduce backlogs on investigations and deviations.Assisted with PAI readiness and mock audits
Apr 2014 - May 2015
Director Of Quality Assurance
Managed QA/QC staff of 4 FTEs and 1 consultant, including the Document Control group. Performed gap assessments of CMOs, led QA audits of CMOs and CROs (PAI, BIMO), implemented Quality Agreements, and performed QA review of clinical reports. Provided Quality Management Reviews (QMRs) to upper management. Reviewed human factor reports and set up site auditsM
Dec 2013 - Jul 2014
Director Qa
Proteolix/ Onyx
Managed 12 people consisting of Quality Systems Managers, Document QA specialists, QA Auditors and several consultants. Provided QA support to clinical on in-life audit of CROs. Conducted routine and for cause GLP and GMP audits of CMOs, including domestic and foreign contract API and final DP manufacturers, labeling, packaging and receiving facilities
Jul 2007 - Mar 2013
Qa Director
2000 - 2007
~7 yrs
Qc Manager
Cygnus
Sep 1996 - May 1998
Team & coworkers
Colleagues at Nurix Therapeutics
Other employees you can reach at nurixtx.com. View company contacts for 129 employees →
AS
Amanda Schwab
Colleague at Nurix Therapeutics
Los Angeles, California, United States, United States
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DM
Davorka Messmer, Ph.D.
Colleague at Nurix Therapeutics
San Diego County, California, United States, United States
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ML
Mitchell Lavarias, Ph.D
Colleague at Nurix Therapeutics
San Francisco, California, United States, United States
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TK
Tim Kane
Colleague at Nurix Therapeutics
San Francisco, California, United States, United States
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YS
Ying Siow (May) Tan
Colleague at Nurix Therapeutics
San Francisco Bay Area, United States
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MM
Michael Mormino
Colleague at Nurix Therapeutics
South San Francisco, California, United States, United States
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JS
Jamar Santiago
Colleague at Nurix Therapeutics
Newark, California, United States, United States
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JW
Jeffrey W.
Colleague at Nurix Therapeutics
Alameda, California, United States, United States
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EL
Emily Low
Colleague at Nurix Therapeutics
Greater Boston, United States
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SM
Saloni Malla, Phd
Colleague at Nurix Therapeutics
San Francisco, California, United States, United States
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Amanda Schwab
Colleague at Nurix Therapeutics
Los Angeles, California, United States, United States
View →
DM
Davorka Messmer, Ph.D.
Colleague at Nurix Therapeutics
San Diego County, California, United States, United States
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ML
Mitchell Lavarias, Ph.D
Colleague at Nurix Therapeutics
San Francisco, California, United States, United States
View →
TK
Tim Kane
Colleague at Nurix Therapeutics
San Francisco, California, United States, United States
View →
YS
Ying Siow (May) Tan
Colleague at Nurix Therapeutics
San Francisco Bay Area, United States
View →
MM
Michael Mormino
Colleague at Nurix Therapeutics
South San Francisco, California, United States, United States
View →
JS
Jamar Santiago
Colleague at Nurix Therapeutics
Newark, California, United States, United States
View →
JW
Jeffrey W.
Colleague at Nurix Therapeutics
Alameda, California, United States, United States
View →
EL
Emily Low
Colleague at Nurix Therapeutics
Greater Boston, United States
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SM
Saloni Malla, Phd
Colleague at Nurix Therapeutics
San Francisco, California, United States, United States
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2 education records
Mike Roth education
Master'S Degree, Pharmacological Oncology
Ma, Pharmacology
FAQ
Frequently asked questions about Mike Roth
Quick answers generated from the profile data available on this page.
What company does Mike Roth work for?
Mike Roth works for Nurix Therapeutics.
What is Mike Roth's role at Nurix Therapeutics?
Mike Roth is listed as Strategic Global Quality & Compliance Exectutive | Pharmaceutical / Biotech Industry Excellence | Leading Clients to Optimize Growth | Consultant & ASQ Certified Qualified Auditor at Nurix Therapeutics.
Where is Mike Roth based?
Mike Roth is based in San Francisco Bay Area, United States, United States while working with Nurix Therapeutics.
What companies has Mike Roth worked for?
Mike Roth has worked for Nurix Therapeutics, Rain Oncology, Principia Biopharma/ Sanofi, Rigel Pharmaceuticals Inc., and Zosano Pharma.
Who are Mike Roth's colleagues at Nurix Therapeutics?
Mike Roth's colleagues at Nurix Therapeutics include Amanda Schwab, Davorka Messmer, Ph.D., Mitchell Lavarias, Ph.D, Tim Kane, and Ying Siow (May) Tan.
How can I contact Mike Roth?
You can use AeroLeads to view verified contact signals for Mike Roth at Nurix Therapeutics, including work email, phone, and LinkedIn data when available.
What schools did Mike Roth attend?
Mike Roth holds Master'S Degree, Pharmacological Oncology from University At Buffalo.
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