Jeffrey Torres
Quality and Compliance Leader | Audits | Quality Systems | Computer Systems | Data Integrity | PDA SE Board Member
- Role
- Computer Compliance Audit Manager at GSK
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Jeffrey Torres
J••••••••@gmail.com (91••••••69I am a Systems Builder. What I do:* Build quality systems or systems that have software.* Assess systems for gaps or compliance to internal SOPs or industry standards.* Lead projects to devise strategy, create and implement improvements to make the necessary changes.* Devise ways of filling in those gaps by creating policies, procedures, work instructions and providing training.* Lead projects to implement systems that have software throughout the systems development lifecycle, including risk assessments.* Operate a system to enhance and make it simpler and more efficient.Extensive accomplishments in managing teams and projects, quality assurance and software development life cycle (SDLC) in Biotech, Pharmaceutical and Medical Device industries. Core Competencies Team and Project Leadership / Management Quality Systems (21 CFR 211, 820, ISO 9001, ISO 13485)Internal Audits and Supplier AuditsData Integrity Risk Management (ICH Q9, ISO 14971)Computer Systems SDLC and Validation 21 CFR Part 11 / EU Annex 11Design Controls Specialties Quality Systems (Analysis, Development, Implementation and Process Improvement), Auditing (internal and external suppliers), Risk Management (ICH Q9, ISO 14971), Computer System Validation and interpreting GXP regulations.
Experience
Computer Compliance Audit Manager
Aug 2024 — Present · Durham, NC, US
Responsible for managing third-party computer compliance audits.
Education
North Carolina State University
Master of Business Administration (M.B.A.), Finance
2004 — 2007
Rensselaer Polytechnic Institute
Bachelor's Degree, Computer & Systems Engineering
1981 — 1985
Skills
- Internal Audit
- Gmp
- Quality System
- Quality Systems
- V&V
- Process Simulation
- Risk Management
- Lims
- Quality Management Systems
- Cgmp
- Pharmaceutical Industry
- Business Process Improvement
- Sop
- Fda
- Software Documentation
- Sdlc
- Process Improvement
- Microsoft Office
- Ms Office Suite
- 21 Cfr Part 11
- Change Leadership
- Medical Devices
- Capa
- Iso 9000
- Gamp
- U.s. Food and Drug Administration (Fda)
- Change Control
- Quality Assurance
- Biotechnology
- Project Management
- Eu Annex 11
- Iso 13485
- Cross-Functional Team Leadership
- Life Sciences
- Lifesciences
- Verification and Validation (V&V)
- Supplier Audits
- Gxp
- Computer System Validation
- Facilitators
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