Jeffrey Berman
@jeffreyberman
Quality & compliance expert specializing in Computer System Validation (CSV), GxP, and inspection-ready validation excellence.
United StatesWhat I'm looking for
I’m an experienced Quality and Compliance professional with 25+ years in the pharmaceutical and life sciences industry. I specialize in Computer System Validation (CSV), GxP compliance, and project management—ensuring complex systems and processes meet FDA, EMA, and international regulatory standards.
I’ve supported and improved validation and quality systems across teams at Mallinckrodt, Novavax, Organon, Lannett, and Bristol Myers Squibb, where I reviewed and verified validation documentation, evaluated test scripts, and identified compliance gaps and risks with strong corrective/preventive action focus. Now semi-retired, I’m seeking part-time or consulting roles to share my experience, mentor teams, streamline validation efforts, and help companies strengthen their quality systems while staying inspection-ready.
Experience
Work history, roles, and key accomplishments
Computer System Validation Specialist
Mallinckrodt Pharmaceuticals
Nov 2023 - May 2024 (6 months)
Reviewed, assessed, and verified computer system validation documentation to ensure compliance with global regulatory and corporate quality standards. Conducted periodic reviews of validated systems, evaluated executed test scripts, and identified validation-related compliance gaps and risks.
Quality Reviewer
Novavax Pharmaceuticals
Apr 2022 - Jun 2023 (1 year 2 months)
Provided QA oversight of validation activities to ensure documentation met company procedures and FDA, EMA, and WHO requirements. Coordinated efficient review and approval workflows and resolved validation documentation discrepancies with cross-functional teams.
Senior Specialist, IT Quality Assurance
Organon Pharmaceuticals
Apr 2021 - Apr 2022 (1 year)
Oversaw validation and quality assurance of IT and GxP computerized systems for global compliance. Prepared and reviewed validation documentation, supported internal and external audits, and implemented process improvements for validation document management.
Validation/CSV SME & Quality Analyst
Various Pharmaceutical Firms
Jul 2013 - Nov 2016 (3 years 4 months)
Served as a CSV subject-matter expert and quality analyst supporting validation-related quality requirements across pharmaceutical firms.
Education
Degrees, certifications, and relevant coursework
Temple University
Bachelor of Business Administration, Accounting
Bachelor of Business Administration in Accounting from Temple University.
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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