Grifols · 1 month ago
Sr. Quality Associate II / Principal Quality Associate, Quality Compliance
North Carolina, United States
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expGrifols is a global healthcare company that has been improving health and well-being since 1909. The Principal Quality Associate will provide leadership in quality compliance, support external audits, and lead initiatives for process improvement within the Clayton, NC campus.
BiotechnologyHealth CareManufacturing
Responsibilities
Use expertise to advise and influence the technical decisions of business units
Demonstrates the ability to influence the decision makers in other departments
Has excellent communication skills (written and verbal) with demonstrated use of domestic (i.e. Food and Drug Administration CFR) and applicable foreign regulatory agency requirements/guidelines
Interacts regularly with members of management and as needed with regulatory officials
Leads multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion
May serve as manager delegate with demonstrated experience in Quality Systems and with GT products/processes
Prepares, organizes, and tracks documentation and requests in support of regulatory and customer audits
Authors, reviews, and revises responses to regulatory and customer audits
Coordinates and manages logistics of on site and remote regulatory and customer audits
Track and follow-up on audit commitments and corrective actions
Perform effectiveness checks for audit related corrective actions
Author Quality Agreements for Grifols Suppliers and Customers
Author Biological Product Deviation Reports
Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply
Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Risk Assessments, Incident Tracking System entries and investigation reports
Revise / update and coordinate executive management review of the Grifols Clayton site master file
Manages and provides audit history information to internal customers
Compiles department metrics
Tracks corrective action resolution for near hit observations identified by management during regulatory or customer audits
Partners with stakeholders to identify and implement continuous improvement solutions with demonstrated / measured business results
Provides support to other functions within the Quality Compliance group
Provides guidance and training for other employees
Qualification
Required
BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience for Sr. Quality Associate I
BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience for Sr. Quality Associate II
BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience for Principal Quality Associate
Knowledge of domestic and foreign regulatory authority requirements
Investigation skills with nonconformances including root cause analysis and corrective/preventive actions
Excellent organizational skills and the ability to follow up on matters consistently and diligently until timely resolution is achieved
Demonstrated ability to consistently apply technical knowledge in making sound quality decisions with minimal guidance
Technical report writing skills with the ability to produce high quality documentation appropriate for the intended audience
Ability to think critically/strategically and act proactively
Demonstrates integrity and company values
Follows cGMP and departmental safety practices
Knowledge and experience using Microsoft Office applications
Excellent communication skills (written and verbal) with demonstrated use of domestic (i.e. Food and Drug Administration CFR) and applicable foreign regulatory agency requirements/guidelines
Preferred
SAP Quality Module
Strong Excel skills, familiarity with pivot tables
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
2025-11-19
Company data provided by crunchbase