Michele Sacman

Current

• Consultant at QMC, Inc.

Past

• Associate Director, Clinical Quality Systems at Elan Pharmaceuticals
• Consultant / Project Manager at Pharmaceutical Services Corporation
• Doctoral Candidate at University of Southern California

• GMP Auditor / Chemist, Corporate Analytical Science at ALZA Corporation
• Development Associate at Scios, Inc.

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Recommended

1 person has recommended Michele

Connections

106 connections

Industry

Pharmaceuticals

Websites

• QMC, Inc. Website
• QMC Information Sheet

Michele Sacman’s Summary

Consultant 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 experience 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.

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.

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.

Michele Sacman’s Specialties:

Develop and implement quality systems; vendor audits; inspection readiness; clinical trials and regulatory affairs 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 validation: LC, GC, LCMS, CE, TOC, ELISA

Facilities validation: HVAC, WFI, BMS, stability, process equipment, cleaning

Michele Sacman’s Experience

• Consultant

  QMC, Inc.

  (Privately Held; 1-10 employees; Biotechnology industry)

  March 2007 — Present (2 years 5 months)

• Associate Director, Clinical Quality Systems

  Elan Pharmaceuticals

  (Public Company; Biotechnology industry)

  2001 — 2007 (6 years)

• Consultant / Project Manager

  Pharmaceutical Services Corporation

  (Privately Held; Biotechnology industry)

  2001 — 2003 (2 years)

• Doctoral Candidate

  University of Southern California

  (Higher Education industry)

  1999 — 2001 (2 years)

• GMP Auditor / Chemist, Corporate Analytical Science

  ALZA Corporation

  (Public Company; Pharmaceuticals industry)

  1995 — 1999 (4 years)

• Development Associate

  Scios, Inc.

  (Public Company; 51-200 employees; Biotechnology industry)

  1994 — 1995 (1 year)

Additional Information

Michele Sacman’s Websites:

• QMC, Inc. Website
• QMC Information Sheet

Michele Sacman’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• job inquiries
• expertise requests
• reference requests
• getting back in touch