Claus Weisemann
Vice President Quality Alector
- Role
- Vice President Quality at Alector
- Location
- South San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Claus Weisemann
Executive SummaryHighly accomplished Quality and Compliance leader in cGMP/GxP environments. Accumulated noteworthy scientific background as well as international and intercultural experience in pharmaceuticals and biologicals. Possesses successful track record in addressing complex situations and merging viable compliance with operational success across all GxP areas. Recognized for a strong work ethic, integrity, and a high degree of personal initiative.Specialties: GMP | GMP-FDA | GxP | Quality | cGMP Compliance | leadership in operational and corporate environment for | solid oral dosage | transdermal and parenteral formulations.Aseptic processing | sterile filling.Biological | Biotech products | Vaccines | prescription drugs | generic drugs | injectables | transdermalQuality Systems | Quality Control | Clinical QA Management.Analytical Chemistry, Analytical MethodsRegulatory inspections (FDA | EMA | other countries).Leadership for remediation, re-engineering and reorganization processes.Quality leadership in commercial manufacturing across multiple sitesQuality organizationRegulatory submissionsTechnology transferCMO oversightProduct DevelopmentGlobal QualityLeadership in intercultural and international environment | multilingual communication capabilities.Good Clinical Practice (GCP)ValidationChange Control | Deviation Management | CAPAsRisk ManagementOrganic Chemistry (PhD)
Experience
Vice President Quality
Aug 2024 — Present · South San Francisco, CA, US
Leading Quality for all GXP areas (GMP, GLP, GCP) to support Alector\'s clinical and research programs (pre-IND through Phase and to contribute to Alector\'s continued success. Leveraging a scientific approach and the concepts of \"Intelligent Compliance\" and \"Phase-appropriate GxPs\" to right-size Quality and Compliance resources for the optimum impact for each phase.
Education
Ulm University
Ph.D. (Dr. rer. nat.), Organic and Analytical Chemistry
1977 — 1987
University of California, Berkeley, Haas School of Business
Certificate, Artificial Intelligence: Strategies and Business Applications
Lessing Gymnasium, Neu-Ulm, Germany
Abitur , Prep school with focus on foreign languages
1969 — 1977
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Life Sciences
- Computer System Validation
- Laboratory Information Management System (Lims)
- Risk Management
- Lims
- Regulatory Submissions
- Leadership
- Capa
- R&D
- Good Clinical Practice (Gcp)
- Quality Control
- Gmp
- Pharmaceutics
- Good Laboratory Practice (Glp)
- Gcp
- Biopharmaceuticals
- Cleaning Validation
- Generic Drugs
- Change Control
- Iso 13485
- Technology Transfer
- Corrective and Preventive Action (Capa)
- Standard Operating Procedure (Sop)
- Trackwise
- Regulatory Requirements
- Ind
- Validation
- Glp
- Regulatory Affairs
- 21 Cfr Part 11
- Gxp
- Quality Auditing
- Aseptic Processing
- U.s. Title 21 Cfr Part 11 Regulation
- U.s. Food and Drug Administration (Fda)
- Manufacturing
- Quality Assurance
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