Richard Herling
Sr. Director GxP Operations at Ultragenyx Pharmaceutical Inc. (He/Him)
- Role
- Sr Director, Gxp Compliance & Cmc Inspection Management at Ultragenyx
- Location
- Sacramento, CA, US
- LinkedIn followers
- 500 followers
About Richard Herling
In my 22 years in biotechnology, and now rare disease and cell and gene therapy, I have focused on GxP Compliance and Learning and Development roles in the Quality and Manufacturing arenas. I am currently responsible for Ultragenyx\'s GxP Compliance program. Over the years, I have developed L&D programs, processes, tools and curricula in QC, QA, IMP, Quality Systems, GMP Audit and Inspection Management. Currently, working in a rare and ultra-rare disease, cell and gene therapy, mRNA and biotechnology company, I am applying my experience in novel ways. We are a small group that responds quickly and compliantly to new business needs and expectations. My passion is developing GxP compliance audit processes that support and streamline decision making.In my previous role, I implemented Roche\'s ISPI Award winning Auditor Certification Program, a learning solution designed to achieve the following business objectives:• Improve the quality of audits across the business• Reduce the risk to Health Authority inspections as it relates to auditor’s skills and knowledge• Reduce the variability of how audits are conducted• Reduce the time to competency of new auditorsI am passionate about ensuring that patients have access to rare medications by ensuring that leaders understand true compliance risk.
Experience
Sr Director, Gxp Compliance & Cmc Inspection Management
Aug 2023 — Present · Novato, CA, US
Education
Humboldt State University
BS, Marine Biology
1991 — 1995
University of Delaware
Biology
1989 — 1991
Skills
- Gmp Audit
- U.s. Food and Drug Administration (Fda)
- Data Integrity
- Quality Assurance
- Supply Chain Management
- Process Improvement
- Mhra
- Validation
- Management
- Life Sciences
- Pharmaceutical Industry
- Sop
- Fda
- Third-Party Logistics (3pl)
- Capa
- Rare Diseases
- Cgmp
- Curriculum Development
- Continuous Improvement
- Compliance
- Quality System
- Quality Systems
- Document Management
- Process Simulation
- Cross-Functional Team Leadership
- Lifesciences
- Quality Control
- Gmp
- Standard Operating Procedure (Sop)
- Process Development
- Training Delivery
- Ultra Rare Diseases
- Change Control
- Biopharmaceuticals
- Biotechnology
- Ema
- 21 Cfr Part 11
- Certified Lead Auditor
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