CSV & DI Compliance Manager

JOB SUMMARY Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a CSV & DI Compliance  this role you will establish, govern, and sustain the computerized system validation (CSV) and data integrity (DI) program for all GxP computerized systems at the SPL Waunakee site, across IT business and laboratory systems and OT process systems.

You will set the site’s CSV and DI standards, procedures, and policies across Quality, IT, and Engineering, and direct the IT and OT teams that implement them ensuring that every GxP system is validated, compliant, and defensible under regulatory inspection. This role will manage the CSV Engineer, provide functional direction to the automation engineers performing hands-on OT work, and partner with QA Validation, which retains independent review and final approval.

Serve as the site’s primary computerized systems subject matter expert during FDA, customer, and internal inspections and audits. Perform duties at an elevated degree of professionalism, independence, and sense of ownership.

Responsibilities include:

Own the site’s CSV and data integrity program:
Establish and maintain the standards, procedures, and policies that govern all GxP computerized systems, based on 21 CFR Part 11, 21 CFR Part 211, EU Annex 11, ICH Q7, GAMP 5, and ALCOA+ principles, developed to consensus across IT, Engineering, QA, and Validation and approved through SPL’s quality system.

Direct and oversee the CSV and data integrity work performed by the IT team on business and laboratory systems and by the OT team on process systems, including PLCs, HMIs, SCADA, and historians, setting expectations, reviewing deliverables, and driving both teams to build and maintain defensible systems.

Manage and develop the CSV Engineer and provide functional direction on CSV and data integrity matters to the automation engineers who perform hands-on OT validation and data integrity work.

Build and maintain the site’s risk-based CSV and data integrity program plan:
Prioritize systems and gaps by patient safety, product quality, and data integrity risk, sequence the work in phases, and reprioritize as new gaps are identified.

Lead and track CSV and data integrity compliance gap remediation, including CAPA actions and findings from data integrity assessments, and coordinate completion across departments.

Govern the CSV lifecycle for all GxP computerized systems, from requirements through periodic review and retirement, in coordination with the System Owners and Process Owners in IT, Engineering, Quality, and Operations.

Govern the data integrity program across all GxP computerized systems, including account and role-based access governance, audit trail review expectations, time synchronization, backup and restore evidence, and exception handling.

Maintain the site’s GxP computerized system inventory and configuration baselines and make GxP impact and GAMP 5 classification determinations using the governing SOP’s classification principles as the reference.

Develop validation-ready documentation standards and templates that QA Validation can execute and approve against, and review validation strategies and deliverables with recommendations; validation execution and final approval remain with QA Validation.

Ensure CSV and data integrity impact assessment within change control for every change…