Grifols · 3 days ago
Director, Center Quality Ops
North Carolina, United States
Full-time
Hybrid
Director/Executive
10+ years expGrifols is a global healthcare company that has been improving health and well-being since 1909. The Director of Quality Operations ensures compliance with FDA and PPTA regulations across plasma donor centers in the United States while providing strategic leadership and oversight of the Quality Management System.
BiotechnologyHealth CareManufacturing
Responsibilities
Lead and develop a national Quality Operations team
Establish strategic priorities for Quality Operations aligned with corporate goals
Ensure effective communication, collaboration, and alignment with Operations, Medical Affairs, Regulatory, and Quality counterparts
Ensure donor centers comply with US FDA, EMA, PPTA IQPP standards, CLIA/COLA, and state regulations
Maintain audit and inspection readiness across all centers
Oversee investigations, deviations, CAPAs, complaints, donor safety events, and product quality issues
Oversee implementation and effectiveness of QMS elements at Donor Center level: Change Control, Document Management, CAPA, Training, Risk Management, Supplier Quality
Ensure procedures are implemented consistently and updated according to regulatory or corporate requirements
Support harmonization of quality processes across all donor centers
Ensure plasma collection, processing, labeling, storage, and shipment meet GMP and IQPP standards
Monitor product quality trends
Support product release, hold disposition, and quality decisions impacting customers
Establish and track quality metrics, KPIs, dashboards, and trends for Donor Centers
Communicate performance and risk indicators for Donor Centers to senior leadership
Lead continuous improvement initiatives and process optimization for Donor Centers
Partner with Operations, Engineering, IT, Medical, Supply Chain, and Regulatory Affairs to ensure integrated, compliant processes at Donor Center level
Support equipment qualification, calibration programs, system validation, and operational readiness for new technologies
Ensure ongoing training and competency development for Quality staff at Donor Centers level
Promote a proactive quality mindset with strong ownership at Donor center level
Lead initiatives to strengthen quality behavior and compliance across donor centers
Solves complex operational and compliance issues requiring interpretation of regulations, trend analysis, and cross-functional inputs
Apply risk-based decision making and scientific reasoning to determine corrective actions, process improvements, and quality controls
Able to anticipate and prevent quality risks across multiple centers
Approves quality decisions affecting donor safety, product quality, and regulatory compliance
Together with Quality Assurance Director, makes determinations on deviations, investigations, holds, CAPAs, and procedural adherence
Escalates significant issues to VP US Plasma Quality & Medical and Quality Assurance Director, as needed
Helps define strategic quality priorities for the plasma collection network
Qualification
Required
Bachelor's in Life Sciences, Pharmacy, Biology, Nursing or related field (required)
Typically requires 10 years in GxP or plasma/biologics Quality roles
5+ years leading multi-site Quality Operations teams
Strong inspection management experience (FDA, EMA, PPTA, CLIA/COLA, State, internal audits)
Experience with QMS systems (TrackWise, etc.)
Deep knowledge of FDA/EMA/PPTA/WHO and applicable regulations or guidances
Leadership and people development
Proven success in driving cross-functional improvements
Risk management and root-cause analysis
Analytical and data-driven mindset
Excellent communication, negotiation, and influencing skills
Operational excellence and continuous improvement capability
Preferred
Master's degree preferred
Benefits
Medical
PTO
Up to 5% 401K match
Tuition reimbursement
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