Grifols is seeking a Director, Center Quality Operations to provide strategic and operational leadership for quality across all US plasma donor centers. In this role, you will ensure consistent compliance with FDA, PPTA, and corporate standards, oversee the Quality Management System, and champion donor safety and product quality.
What You'll Do
- Lead and develop a national Quality Operations team including Regional Quality Managers and center personnel.
- Establish strategic priorities aligned with corporate goals and ensure compliance with FDA, EMA, PPTA IQPP, CLIA/COLA, and state regulations.
- Maintain audit and inspection readiness across all centers, overseeing investigations, deviations, CAPAs, and donor safety events.
- Oversee the implementation and effectiveness of QMS elements at the donor center level, including Change Control, Document Management, Training, and Risk Management.
- Ensure procedures are consistently implemented and updated according to regulatory or corporate requirements.
- Support harmonization of quality processes and ensure plasma collection, processing, labeling, storage, and shipment meet GMP and IQPP standards.
- Monitor product quality trends and support product release, hold disposition, and quality decisions impacting customers.
- Establish and track quality metrics, KPIs, and dashboards, communicating performance and risk indicators to senior leadership.
- Lead continuous improvement initiatives and process optimization for donor centers.
- Partner cross-functionally with Operations, Engineering, IT, Medical, Supply Chain, and Regulatory Affairs to ensure integrated, compliant processes.
- Support equipment qualification, calibration programs, system validation, and operational readiness for new technologies.
- Ensure ongoing training and competency development for Quality staff and promote a proactive quality mindset.
- Lead initiatives to strengthen quality behavior and compliance across donor centers.
- Solve complex operational and compliance issues requiring regulatory interpretation, trend analysis, and cross-functional input.
- Apply risk-based decision making and scientific reasoning to determine corrective actions and process improvements.
- Anticipate and prevent quality risks across multiple centers.
- Approve quality decisions affecting donor safety, product quality, and regulatory compliance.
- Together with the Quality Assurance Director, make determinations on deviations, investigations, holds, CAPAs, and procedural adherence.
What We're Looking For
- Proven experience ensuring compliance with US FDA, EMA, PPTA IQPP standards, CLIA/COLA, and state regulations in a plasma, blood, or pharmaceutical environment.
- Extensive background in leading quality operations, including overseeing a Quality Management System, product quality, and donor safety programs.
- Strong leadership skills with experience managing national or regional quality teams.
- Deep expertise in managing audits, inspections, investigations, deviations, and CAPA systems.
- Ability to establish strategic priorities, track performance metrics, and communicate effectively with senior leadership.
- Expertise in applying risk-based decision making and scientific reasoning to complex compliance and operational issues.
Team & Environment
You will lead a national Quality Operations team, including Regional Quality Managers and quality personnel at donor centers, providing strategic direction and fostering a culture of quality and compliance across the organization.
Grifols is an equal opportunity employer.
