Resumes
Resumes

Director, Regulatory Compliance - External Manufacturing
View pageLocation:
York, PA
Industry:
Pharmaceuticals
Work:
Johnson & Johnson
Director, Regulatory Compliance - External Manufacturing
Johnson & Johnson
Director, J and J Regulatory Compliance
Johnson & Johnson May 2011 - Oct 2012
Director, Regulatory Compliance, Audit Management
Adhesives Research, Inc. Oct 2006 - May 2011
Director, Quality and Compliance
Johnson & Johnson 2004 - 2006
J and J and Merck Cpc - Manufacturing Manager
Director, Regulatory Compliance - External Manufacturing
Johnson & Johnson
Director, J and J Regulatory Compliance
Johnson & Johnson May 2011 - Oct 2012
Director, Regulatory Compliance, Audit Management
Adhesives Research, Inc. Oct 2006 - May 2011
Director, Quality and Compliance
Johnson & Johnson 2004 - 2006
J and J and Merck Cpc - Manufacturing Manager
Education:
Chestnut Hill College
Bachelors, Bachelor of Science, Chemistry
Bachelors, Bachelor of Science, Chemistry
Skills:
Capa
Fda
Gmp
Validation
Quality System
Change Control
Quality Assurance
Quality Auditing
Pharmaceutical Industry
Medical Devices
Quality Control
21 Cfr Part 11
Cross Functional Team Leadership
Six Sigma
U.s. Food and Drug Administration
Iso 13485
Gxp
Corrective and Preventive Action
V&V
Leadership
Iso
Process Improvement
Trackwise
Manufacturing
Continuous Improvement
Technology Transfer
Sop
Lims
R&D
Cqa
Aseptic Processing
Cleaning Validation
Regulatory Requirements
Quality Management
Biopharmaceuticals
Computer System Validation
Glp
Iso Standards
Iso 14971
Biotechnology
Analytical Chemistry
Hplc
Chemistry
Pharmaceutics
Design Control
Root Cause Analysis
Auditing
Regulatory Submissions
Vaccines
Chromatography
Regulatory Affairs
Process Simulation
Gamp
Fda
Gmp
Validation
Quality System
Change Control
Quality Assurance
Quality Auditing
Pharmaceutical Industry
Medical Devices
Quality Control
21 Cfr Part 11
Cross Functional Team Leadership
Six Sigma
U.s. Food and Drug Administration
Iso 13485
Gxp
Corrective and Preventive Action
V&V
Leadership
Iso
Process Improvement
Trackwise
Manufacturing
Continuous Improvement
Technology Transfer
Sop
Lims
R&D
Cqa
Aseptic Processing
Cleaning Validation
Regulatory Requirements
Quality Management
Biopharmaceuticals
Computer System Validation
Glp
Iso Standards
Iso 14971
Biotechnology
Analytical Chemistry
Hplc
Chemistry
Pharmaceutics
Design Control
Root Cause Analysis
Auditing
Regulatory Submissions
Vaccines
Chromatography
Regulatory Affairs
Process Simulation
Gamp
Certifications:
Iso13485 Lead Auditor