NCNicole Caudell
@nicolecaudell
Quality Systems Manager ensuring cGMP compliance through audits, process improvement, and team leadership.
United StatesWhat I'm looking for
I’m a Center Quality/Quality Systems Manager with over ten years of multifaceted experience in quality assurance and control, operations management, problem resolution, and compliance adherence. I strengthen organizational growth through data analysis and process improvement while ensuring alignment with cGMP regulatory requirements and standard operating procedures (SOPs).
In my current role at DB Biologics, I oversee quality systems for alignment with cGMP and SOPs, analyze processes for compliance with state, federal, and company guidelines, and serve as the regional point of contact. I conduct quality assurance audits, track and trend risks to donor/product safety from non-compliance, manage documentation and approvals (deviations, CAPAs, change controls), and ensure CLIA required proficiency testing is executed and reported on time.
Experience
Work history, roles, and key accomplishments
Quality Systems Manager
DB Biologics – DB Plasma
Dec 2024 - Present (1 year 4 months)
Oversee center quality systems to align with cGMP requirements and SOPs, leading QA audits, documentation review, and deviation/CAPA/change control approvals. Support regional compliance as the point of contact and manage CLIA proficiency testing execution, trend reporting, and donor/product safety impact assessments; DB Biologics purchased 5 Biomat centers with Dayton as one location.
Quality Systems Manager
Biomat USA – Grifols/Talecris Plasma Resources
Nov 2013 - Dec 2024 (11 years 1 month)
Managed quality systems across center, regional, and business units to ensure alignment with cGMP requirements and SOPs, including QA audits, documentation review, and approval of QA actions (deviations, CAPAs, change controls). Supported operations continuity by covering interim regional/center/quality/training roles, leading onboarding/training efforts, and producing monthly and quarterly track-
Education
Degrees, certifications, and relevant coursework
SUSouthern New Hampshire University
Associate degree, Business
Associate degree (general associates) with a concentration in business from Southern New Hampshire University.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Salary expectations
Social media
Skills
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