Scientific Protein Laboratories,
The CSV & DI Compliance Manager establishes, governs, and sustains the computerized system validation and data integrity program for all GxP computerized systems at the SPL Waunakee site. This role sets site standards, procedures, and policies across Quality, IT, and Engineering, while directing IT and OT teams to ensure all systems are validated, compliant, and defensible under regulatory inspection. The position serves as the primary subject matter expert during FDA, customer, and internal inspections and audits.
Scientific Protein Laboratories (SPL) is a Waunakee, WI-based pharmaceutical company with over 30 years of experience in the development and cGMP-compliant manufacturing of active pharmaceutical ingredients (APIs) from naturally derived sources. SPL's core products include heparin and its analogs, pancreatin, and other biologics, with capabilities spanning fermentation, natural product extraction, and recovery and purification. The company also provides custom development and manufacturing services to emerging and established biopharmaceutical companies worldwide.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
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