Grifols · 1 day ago
Manager, Quality / Sr. Manager, Quality (QA Fractionation)
NC-Clayton
Full-time
Onsite
Senior Level
6+ years expGrifols is a global healthcare company dedicated to improving health and well-being. The Manager/Sr. Manager of Quality is responsible for overseeing the Quality Assurance Fractionation Business Unit, managing quality systems, compliance, and leading a team to ensure regulatory standards are met.
BiotechnologyHealth CareManufacturing
Responsibilities
Manages all aspects of the QA Fractionation Business Unit (quality systems, overall compliance, oversee department budget, employee relations, etc.)
Follows cGMP and department safety practices
Provides guidance as well as consult with manufacturing, maintenance, logistics, and internal regulatory departments on GXP matters
Uses expertise and sound judgment to make independent decisions within defined areas of responsibility
Plans and analyzes workflow, delegate and prioritize, to ensure that assignments and projects are completed in a timely manner and within projected budget
Participates in regulatory inspections/customer audits including providing written responses as applicable for area of responsibility
Practices high level of facilitations skills to reach consensus and works toward solutions
Review and revise Standard Operating Procedures and generate reports
Investigates and initiates corrective actions for quality related issues
Collaborates and efficiently communicates to internal and external customers
Applies quality risk-based processes to seek continuous improvement of systems, processes, and facilities
Provides effective leadership to employees in the Quality Assurance Fractionation Business Unit
Demonstrates high levels of value and integrity
Demonstrated skills in managing projects to bring in on budget, on schedule, and technically correct (Sr. Manager level)
Provides Quality support, reviews and approvals of regulatory labeling and submissions
Provides QA support of NFF and NFB pooling and fractionation processes
These processes include pool record review and release, shipment of pool samples to EU regulatory authorities for testing and approvals, review and release of intermediate shipments to contract customers as well as intermediate shipment receipts from other Grifols manufacturers
Responsibilities may include roles such as document author/reviewer or approver in the administration of quality systems such as Change Control, Discrepancy Management, Intermediate Quarantine, pool and fractionation Batch Record review, documentation, SAP Master Data, and Annual Product Reviews as well as provide Quality input for validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions
Responsible for representing QA Fractionation at manufacturing business unit meetings, and project meetings
Qualification
Required
PHD in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, technology, engineering, math, or computer science) with minimum of 6 years relevant experience
MS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, technology, engineering, math, or computer science) with minimum of 8 years relevant experience
BS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, technology, engineering, math, or computer science) with minimum of 10 years relevant experience
At least 2 years of previous supervisory experience
Excellent communication skills (written and verbal)
Extensive working knowledge of applicable regulations (i.e. U.S. Food and Drug Administration, Eudralex, Health Canada) and other applicable regulatory agency requirements/guidelines
Ability to perform methodical, risk-based analysis of situations and propose improvements
Good organizational skills and ability to follow up on items to completion in a timely manner
Preferred
Previous experience with plasma, pools, fractionation and intermediate products
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