Senior Quality Systems Specialist, Quality Operational Readiness

Grifols

. Support implementation and operational readiness of Quality functions at new Biopharma manufacturing facilities and new processes/facilities at existing sites .

Posted 11/4/2026full-timeClayton • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Regulatory Compliance within Biopharma manufacturing, with a strong focus on operational readiness, risk mitigation, and continuous improvement. Proficient in collaborating across multidisciplinary teams to implement effective quality systems and solutions.

Highest-signal resume keywords

PhD In Life Sciences, Chemical Sciences, Or Relevant DegreeUnderstanding Of Regulatory Requirements (U.S. FDA, EMA, Health Canada)Project Management Skills For Quality InitiativesProficiency In Identifying And Mitigating Quality RisksProven Communication Skills For Diverse Stakeholders

ATS Keywords

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Hard Skills

Quality AssuranceRegulatory ComplianceRisk AssessmentData AnalysisProject ManagementGMP StandardsValidation Master PlansContinuous ImprovementOperational ReadinessTechnology Transfer

Soft Skills

CollaborationProblem SolvingIndependent ExecutionCommunicationRelationship Building

Industry Keywords

BiopharmaManufacturingQuality FunctionsRegulatory InspectionsMock AuditsGap AssessmentsStakeholder EngagementKPI MonitoringQuality SystemsLife Sciences

About the role

Key responsibilities & impact

Support implementation and operational readiness of Quality functions at new Biopharma manufacturing facilities and new processes/facilities at existing sites
Facilitate transfer of knowledge and best practices from established Grifols sites through the Technology Transfer process
Collaborate with Engineering, Manufacturing, Regulatory Affairs, IT, site Quality, Validation, and Global Quality teams
Translate strategic objectives and stakeholder requirements into deliverables, recommendations, and implementation plans
Execute Operational Readiness deliverables independently and escalate risks, barriers, and recommended solutions
Monitor project timelines, quality milestones, risk mitigation plans, and KPIs; report results to stakeholders and senior management
Prepare sites for regulatory inspections through planning, mock audits, gap assessments, and practice sessions
Assist with review of validation master plans, sampling plans, master data setup, site master files, product specifications, and raw material specifications
Recommend quality improvements and support problem solving and mitigation of quality risks using risk-based approaches
Develop working relationships across Manufacturing, Quality, Validation, Engineering, Regulatory Affairs, and Global Quality
Visit production plants, conduct GMP-area walkthroughs, identify continuous improvement opportunities, and partner with site management on implementation
Develop proactive quality-related solutions and robust quality systems for effective operations and regulatory review
Drive and monitor continuous improvement and operational preparedness activities
May serve as manager delegate when applicable

Requirements

What you’ll need

PhD in a Life Sciences, Chemical Sciences, or relevant degree with a minimum of 4 years relevant experience OR MS in a Life Sciences, Chemical Sciences, or relevant degree with a minimum of 6 years relevant experience OR BS in a Life Sciences, Chemical Sciences, or relevant degree with a minimum of 7 years relevant experience OR an equivalent combination of education and experience
STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science
Understanding of regulatory requirements including U.S. FDA, EMA, and Health Canada
Ability to analyze data and metrics
Proven communication skills for technical and non-technical concepts and diverse stakeholders
Ability to independently execute assignments and own deliverables
Proficiency in identifying, assessing, and mitigating product quality and compliance risks
Ability to identify quality issues and recommend effective solutions
Ability to collaborate with departments and external partners
Project management skills for multiple quality initiatives and projects
Ability to rapidly absorb, retain, and apply new information across disciplines
Ability to travel 15% to 50%, including international travel
Ability to frequently drive to site locations and travel within the United States
Ability to lift and carry up to 25 pounds

Benefits

Comp & perks

15% to 50% travel to other Biopharma sites, including international travel
Equal employment opportunities and consideration consistent with applicable laws