Director, QA Compliance
Greater Los Angeles Area
- Current
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- Director, QA Compliance at Cougar Biotechnology
- Consultant at QMC, Inc.
- Past
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- Associate Director, Clinical Quality Systems at Elan Pharmaceuticals
- Project Manager at Pharmaceutical Services Corporation
- Doctoral Candidate at University of Southern California
- GMP Auditor / Chemist, Analytical Science at ALZA Corporation
- Development Associate at Scios, Inc.
- Education
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- University of Southern California
- San Jose State University
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Michele Sacman’s Summary
Quality Director working with biotechnology and pharmaceutical companies in Quality Systems, Compliance, Project Management, Business Analysis, Validation, and Quality Assurance functions with strong understanding of the drug development process, clinical trials support, and regulatory requirements.
Quality and regulatory compliance specialist with expertise in development and implementation of quality systems, procedures, and business practices that comply with FDA, ICH, QSR, ISO, GMP, GLP, GCP, GAMP, 21 CFR Part 11, and international standards.
Certified lead auditor with significant expertise in internal audits of clinical and commercial quality systems, and external audits of contract manufacturing organizations, contract laboratories, contract research organizations, material suppliers, service vendors, and IT services and software providers.
Validation specialist, business analyst, and project manager with working knowledge of enterprise-wide software systems, laboratory and manufacturing equipment, research and manufacturing facility start-up. Computer systems validation (CSV) through full software development life cycle for pharamceutical business processes, clinical data capture, and supply chain management.
Michele Sacman’s Specialties:
Develop and implement quality systems; vendor audits; inspection readiness; regulatory compliance; clinical trials support
Enterprise-wide custom/COTS software validation: LIMS, SAP ERP, EDMS, EDC, CDS, LiveLink, Documentum, ISOTrain, ComplianceWire, Trackwise, CalMan, Argus Safety, Oracle AERS, Oracle Clinical, MedDRA, eQCM, SAS, IVRS, Chemstation, SoftMax
Equipment and facilities validation: LC, GC, LCMS, CE, TOC, ELISA, HVAC, WFI, BMS, stability, process equipment, cleaning
Michele Sacman’s Experience
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Director, QA Compliance
Cougar Biotechnology
(Public Company; Pharmaceuticals industry)
August 2008 — Present (1 year 4 months)
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Consultant
QMC, Inc.
(Privately Held; Biotechnology industry)
March 2007 — Present (2 years 9 months)
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Associate Director, Clinical Quality Systems
Elan Pharmaceuticals
(Public Company; ELN; Pharmaceuticals industry)
2001 — 2007 (6 years )
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Project Manager
Pharmaceutical Services Corporation
(Privately Held; Biotechnology industry)
2001 — 2003 (2 years )
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Doctoral Candidate
University of Southern California
(Educational Institution; Higher Education industry)
1999 — 2001 (2 years )
Thesis: Effects of high carbohydrate and high long chain fatty acid availability on skeletal muscle fatty acid metabolism and regulation of substrate oxidation
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GMP Auditor / Chemist, Analytical Science
ALZA Corporation
(Public Company; JNJ; Pharmaceuticals industry)
1995 — 1999 (4 years )
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Development Associate
Scios, Inc.
(Public Company; 51-200 employees; Biotechnology industry)
1994 — 1995 (1 year )
Michele Sacman’s Education
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University of Southern California
MS , Physiology , 1999 — 2002
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San Jose State University
BS , Systems Physiology , 1990 — 1994
Michele Sacman’s Contact Settings
Interested In:
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- consulting offers
- job inquiries
- expertise requests
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