Bob Sturm is a eficient expert, working in Elan Pharmaceuticals as a Director, IT Validation from 2007. This person gained professional experience in more than seven positions at various companies. Bob Sturm went to the Rensselaer Polytechnic Institute and received education there. San Francisco, California is the area, where this professional was known to settle. Their e-mail and phone are accessed through this website by request.
Name variants:
Robert Sturm
Last updated Jul 05, 2024
Contact Information
Last Update
Feb 1, 2016
Location
San Francisco, CA
Company
Elan Pharmaceuticals
Workplace
Director, IT Validation
Work History
Director, IT Validation
• Managed/led all aspects of CSV on global project teams for all GxP systems (Argus Drug Safety, Submissions Management, Documentum, SAP, SharePoint, SLIMStat, eLearning, corporate complian...
Nov 2007 — Apr 2013
Director, Computer Validation Compliance
• Enabled company growth by managing computer validation projects for the following implementations: Oracle ERP, QUMAS document management, Submissions Management, Clinical Data Management...
Apr 2005 — Nov 2007
Senior Director, Pharmaceutical Applications
• Managed seven validation projects of new software releases. Managed software validation audits.
Wrote/implemented SDLC and IQ/OQ/PQ procedures and SOPs for CSV and Quality Assurance.
• ...
2002 — 2005
Consulting Manager
Genentech, Inc., So. San Francisco, CA
• Managed multiple cGMP document management projects ($1 million+) and teams for the manufacturing organization. Managed quality, consistency, and...
1999 — 2002
Clinical and Regulatory Information Systems, Associate Director
• Designed, managed, validated, and implemented the following global systems per 21 CFR Part 11 guidelines: Document Management/ Document Imaging with Intranet ability, Adverse Event Repor...
1997 — 1999
Manager of Application Development
• Increased productivity by 15% while managing nine software developers with a $2+ million dollar budget.
• Implemented electronic submissions, document management, document imaging, world...
1994 — 1997
Additional Experience
Consulting Manager (Pharmaceutical Practice) PRICE WATERHOUSE (Global Consulting Co.
Consulting Manager for Pharmaceuticals ORACLE CORPORATION
Director Clinical IT ...
1988 — 1994
Education
Occupations
Executive
Director
IT Professional
SharePoint Administrator
Supporting Member
HR Specialist
Recruitment
Operations Manager
Network Systems Administrator
Network Administrator
Team Member
Skills
Computer System Validation
Software Quality Assurance
Risk Management
FDA
Sop
Validation
21 CFR Part 11
GxP
Biotechnology
Clinical Trials
GMP
Medical Devices
Data Management
Change Control
Pharmaceutical Industry
GCP
Clinical Development
CAPA
V&V
Clinical Data Management
Regulatory Submissions
Quality Assurance
CRO
GAMP
CTMS
Quality System
Document Management
Pharmaceutics
EDC
Oracle Clinical
Lifesciences
Biopharmaceuticals
GLP
LIMS
Clinical Research
Technology Transfer
Protocol
Regulatory Affairs
SDLC
Pharmacovigilance
Regulatory Requirements
Quality Auditing
Testing
FAQs about Bob Sturm
What is the main profession of Bob Sturm?
Bob Sturm is a Director, IT Validation and Infrastructure Qualification.
What are the profession of The professional?
These person's professions are Executive and Director
Where does Bob Sturm currently live?
San Francisco, California is the place where Bob Sturm lives
Where did Bob Sturm work?
This person worked at Elan Pharmaceuticals, Telik, Inc..
Where has Bob Sturm studied?
Bob studied at the Rensselaer Polytechnic Institute.
Are there any awards Bob Sturm received?
Bob Sturm received awards and these awards are: • Quality Assurance in Pharmaceutical Manufacturing, May 2013, ”Utilizing Risk Management within IT Validation to Improve GMP Software Quality” • IVT Computer & Software Validation Conference, April 2012, “Applying Risk Management to Determine How Much Validation is Enough.”.
What is the industry that Bob Sturm worked in?
Bob Sturm works in Pharmaceuticals industry.
Are there any special skills, that Bob Sturm has?
This person has skills in the following areas: Computer System Validation, Software Quality Assurance, Risk Management, FDA, Sop, Validation, 21 CFR Part 11, GxP, Biotechnology, Clinical Trials, and GMP.