Director of Quality Excellence

Grifols

. Lead critical Quality initiatives and ensure projects are executed with appropriate compliance across the U.S.

Posted 10/6/2026full-timeRemote • United StatesLead💰 $177,000 - $265,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality Management within GxP-regulated environments, ensuring compliance with FDA, PPTA, and other regulatory standards while leading cross-functional teams to drive continuous improvement and operational excellence.

Highest-signal resume keywords

Quality Management SystemsRegulatory ComplianceLeadership ExperienceRisk ManagementContinuous Improvement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ManagementRegulatory RequirementsProcess OptimizationDeviation InvestigationCAPARoot Cause AnalysisData AnalysisQuality AuditsPerformance IndicatorsTraining and Development

Soft Skills

LeadershipCoachingCommunicationStakeholder ManagementTeam Development

Tools & Technologies

TrackWiseQuality Management Systems

Industry Keywords

GxPBiologicsPharmaceuticalBiotechnologyFDAPPTACLIACOLAHealthcarePlasma Procurement

About the role

Key responsibilities & impact

Lead critical Quality initiatives and ensure projects are executed with appropriate compliance across the U.S. plasma donor center network
Ensure consistent compliance with FDA, PPTA, and other regulatory requirements
Provide leadership and oversight of continuous improvements, projects, Biosupplies, RSPTO laboratory, and other quality and business needs related to plasma procurement
Support the development and leadership of a national Quality Operations team
Partner with Quality, Medical, and Operations leadership to establish and execute strategic quality objectives
Drive quality-related continuous improvement initiatives and business-critical projects
Promote collaboration across Operations, Medical, Regulatory Affairs, and Quality functions
Ensure donor center compliance with FDA, PPTA IQPP, CLIA/COLA, state, and other applicable regulations
Identify systemic quality risks and implement corrective and preventive actions
Ensure procedures remain current, compliant, and consistently applied
Support harmonization and standardization of quality processes across donor centers
Monitor product quality trends and key performance indicators
Create processes and procedures to improve compliance and consistency from product collection to distribution
Lead process optimization efforts to improve efficiency, compliance, and product quality
Lead and develop traveling quality teams, laboratory staff, and center staff
Foster a proactive quality culture focused on accountability, compliance, and continuous improvement
Ensure ongoing training, coaching, and competency development of quality professionals

Requirements

What you’ll need

Bachelor's degree in Life Sciences, Biology, Pharmacy, Nursing, or a related field required
Master's degree preferred
10+ years of experience in Quality within GxP-regulated, plasma, biologics, pharmaceutical, biotechnology, or related healthcare environments
5+ years of leadership experience overseeing multi-site Quality Operations teams
Demonstrated success managing FDA, PPTA, EMA, CLIA/COLA, state inspections, audits, and regulatory interactions
Experience with Quality Management Systems such as TrackWise or similar platforms
Proven ability to lead cross-functional quality and process improvement initiatives
Extensive knowledge of FDA, EMA, PPTA, WHO, and applicable regulatory requirements
Strong leadership, coaching, and team development skills
Expertise in risk management, deviation investigations, CAPA, and root cause analysis
Analytical, data-driven mindset with strong decision-making capabilities
Excellent communication, influencing, and stakeholder management skills
Demonstrated ability to drive operational excellence and continuous improvement

Benefits

Comp & perks

Up to 30% of the company bonus pool
Medical insurance
Dental insurance
Vision insurance
Life insurance
PTO
Paid holidays
Up to 5% 401(k) match
Tuition reimbursement
Professional growth and career progression opportunities
100% remote work
Travel within the US (20–30%)