Director, Center Quality Ops 1

GRIFOLS, S.A.•NC-RTP, CA

6d•Hybrid

About The Position

The Director of Quality Operations ensures that all plasma donor centers in the United States consistently operate in full compliance with FDA and PPTA regulations, corporate quality standards, and industry best practices. The role provides strategic and operational leadership of Quality Operations across all centers, overseeing the deployment and continuous optimization of the Quality Management System (QMS), product quality, donor safety, and regulatory readiness while fostering a strong quality culture across the organization.

Requirements

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.
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.).

Nice To Haves

Master’s degree preferred.

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.