Mike Roth Email & Phone Number

California, United States

United States

Newark, California, United States

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 and planned NDA/MAA. Responsible for technical quality agreements. Provided routine communication and summary reports to Senior Leadership… Show more 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 and planned NDA/MAA. Responsible for technical quality agreements. Provided routine communication and summary reports to Senior Leadership Team regarding GCP and GMP audits, quality risks and remediation. Liaised with Clinical collaborators and CROs in developing Clinical quality agreements. Show less

South San Francisco, California, United States

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 training module and ComplianceWire training system. Provided initial BIMO and PAI training.

South San Francisco, California, United States

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.

Fremont, California, United States

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.

San Francisco Bay Area

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

Redwood City, California

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

South San Francisco, California

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

San Mateo Ca

Master'S Degree, Pharmacological Oncology

Roswell Park Memorial Cancer Institute

Ma, Pharmacology