Scott Schell
- Role
- Director - Enterprise Regulatory Compliance at Johnson & Johnson
- Location
- West Chester, PA, US
- LinkedIn followers
- 500 followers
About Scott Schell
A Quality Assurance professional with over 25 years of diverse experience in GMP…
Experience
Director - Enterprise Regulatory Compliance
Oct 2011 — Present
Member of the corporate JJRC Assessment and Remediation program designed to provide a cross-sector quality oversight for world-wide operations across the company and to escalate risks to the executive committee. JJRC performs full quality system audits against relevant J&J Policy and Standards, relevant GxP regulations and local procedures. An evaluation of Inspection Readiness is performed.\\\\n• Auditing and Remediation of manufacturing sites from all 3 sectors; Pharmaceutical, Medical Device and Consumer Health Care\\\\n• Auditing and Remediation of Country Marketing companies and associated Distribution Centers.\\\\n• Auditing and Remediation of Corporate GMP Support groups.\\\\n• Perform directed For-Cause audits and Special Investigations.\\\\n• Perform External Manufacturing audits.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
Education
Temple University
MS, Quality Assurance and Regulatory Affairs
2001 — 2005
Lycoming College
BA, Biology
1991 — 1995
Skills
- Software Documentation
- Pharmaceutical Industry
- Capa
- Pharmaceutics
- Iso
- Medical Devices
- Vaccines
- Quality Auditing
- R&D
- Biotechnology
- U.s. Food and Drug Administration (Fda)
- Clinical Trials
- Fda
- Biopharmaceuticals
- Gxp
- Process Improvement
- Quality System
- Quality Assurance
- Quality Management
- Manufacturing
- Auditing
- Sterilization
- Iso 13485
- Gmp
- Aseptic Processing
- Cleaning Validation
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