Director, Center Quality Ops

Primary Responsibilities

• Leadership & Strategic Direction
• 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
• Compliance & Quality Oversight
• 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
• Quality Management System (QMS)
• 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
• Product Quality & Operational Controls
• 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
• Performance Monitoring & Reporting
• 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
• Cross-Functional Collaboration
• 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
• Training, Coaching & Quality Culture
• 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

Additional Responsibilities

• Solving complex operational and compliance issues requiring interpretation of regulations, trend analysis, and cross-functional inputs
• Applying 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
• Decision-Making Authority
• Approve quality decisions affecting donor safety, product quality, and regulatory compliance
• Together with Quality Assurance Director, make determinations on deviations, investigations, holds, CAPAs, and procedural adherence
• Escalate significant issues to VP US Plasma Quality & Medical and Quality Assurance Director, as needed
• Help define strategic quality priorities for the plasma collection network

Knowledge, Skills, and Abilities

• 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

Education and Experience

• Bachelor’s in Life Sciences, Pharmacy, Biology, Nursing or related field (required)
• Master’s degree preferred
• 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.)

Occupational Demands

• Based at RTP headquarters, occasionally remote role with 40–60% travel to US plasma centers
• May require off-hour availability to respond to critical quality events, inspections, or escalations
• Fast-paced, multi-site operational environment