Wilfredo Ortiz
Vice President and Site Head @ Glenmark Pharmaceuticals | Process Improvement
- Role
- Vice President and Site Head at Glenmark Pharmaceuticals
- Location
- Monroe, NC, US
- LinkedIn followers
- 500 followers
About Wilfredo Ortiz
I am a seasoned pharmaceutical executive with over 25 years of experience in operations management, process improvement, quality management systems, and regulatory compliance. As the Vice President and Site Head at Glenmark Pharmaceuticals, a global leader in developing and producing innovative medicines, I oversee the Monroe, NC, manufacturing site that produces aseptically filled pharmaceutical products for various therapeutic areas.My passion is creating dynamic learning environments where people are empowered to excel and deliver. I have successfully led multiple projects and teams designing, constructing, installing, and qualifying equipment and processes for sterile and topical manufacturing and packaging facilities. I also have extensive experience handling GMP inspections by FDA and international agencies, ensuring the highest standards of quality and safety. I aim to leverage my MBA degree and process improvement expertise to drive innovation, efficiency, and growth for Glenmark Pharmaceuticals and the industry.
Experience
Vice President and Site Head
Jul 2021 — Present · Monroe, NC, US
Head of Monroe NC manufacturing site for Glenmark Pharmaceuticals.
Education
University of Puerto Rico-Mayaguez
B.S., Mechanical Engineering
Baylor University - Hankamer School of Business
MBA, Bussiness Management
Skills
- Standard Operating Procedure (Sop)
- Product Development
- Technology Transfer
- Preventive Maintenance
- Cgmp Manufacturing
- Process Improvement
- Cross-Functional Team Leadership
- Packaging
- Gmp
- Biopharmaceuticals
- Pharmaceutical Industry
- Business Process Improvement
- Sop
- Maintenance Management
- Fda
- Continuous Improvement
- Corrective and Preventive Action (Capa)
- Medical Devices
- Capa
- U.s. Title 21 Cfr Part 11 Regulation
- Clean Rooms
- Validation
- 21 Cfr Part 11
- Bulk Heat Sterilization
- Kfda
- Filter Sterilization
- Quality System
- V&V
- Workflow
- Sterilization
- Regulatory Affairs
- Manufacturing Operations Management
- Aseptic Technique
- Aseptic Processing
- Project Management
- U.s. Food and Drug Administration (Fda)
- Plant Layout
- Rab
- Verification and Validation (V&V)
- Lean Manufacturing
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