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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical services quality, regulatory compliance, and operational performance, with a strong focus on continuous improvement and risk mitigation. Proven ability to lead teams, manage complex projects, and ensure adherence to industry standards and regulations.
Highest-signal resume keywords
Regulatory ComplianceQuality OversightTeam DevelopmentData AnalysisClinical Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data AnalysisRoot Cause AnalysisPerformance TrendingSOP DevelopmentDocument ControlRegulatory Inspection ReadinessCorrective ActionsStatistical AnalysisClinical ExperienceBudget Planning
Soft Skills
Team DevelopmentCoaching SkillsEffective CommunicationOrganizational SkillsProblem-Solving Skills
Tools & Technologies
Performance Improvement MethodologiesClinical Laboratory SystemsPrivacy Management Tools
Certifications & Qualifications
Medical Technologist CertificationClinical Laboratory Scientist CertificationSpecialist in Blood Banking CertificationRN Licensure
Industry Keywords
Clinical ServicesRegulated IndustryQuality ManagementRisk MitigationHIPAA Compliance
About the role
Key responsibilities & impact- Provide strategic leadership across Clinical Services quality, regulatory compliance, customer service, operational performance, and risk mitigation.
- Lead, mentor, and develop clinical services quality staff.
- Drive continuous improvement and Operational Excellence initiatives using data analysis, performance trending, root cause analysis, and improvement methodologies.
- Oversee internal assessments, deviation management, investigations, and corrective and preventive actions.
- Lead regulatory inspection readiness and coordinate responses to external agency findings.
- Direct review, validation, approval, and implementation of SOPs, process documentation, and changes.
- Oversee evaluation of nonconforming products, materials, and test results.
- Serve as local Privacy Coordinator and partner on privacy, legal, security, and HIPAA requirements.
- Provide quality and compliance oversight for clinical studies, research activities, and safety management.
- Monitor regulatory and industry developments and guide required changes.
- Contribute to annual budget planning and monitor expenditures.
- Oversee document control activities as needed.
Requirements
What you’ll need- Bachelor's degree required.
- Six years of related experience in a regulated industry required.
- Four years in a quality, regulatory, and/or assessment environment.
- Three years supervisory experience.
- Two years clinical experience in a leadership role (clinical laboratory or apheresis).
- Certification as a Medical Technologist, Clinical Laboratory Scientist, or Specialist in Blood Banking (SBB) by a recognized certifying agency or RN licensure preferred.
- Strong team development and coaching skills.
- Ability to lead and motivate senior and executive-level managers.
- Effective oral and written business communication skills.
- Ability to organize, prioritize, and execute a variable workload and multiple priorities.
- Ability to think strategically, synthesize complex business and financial data, and develop innovative solutions.
- Ability to work in a team environment and participate as an active member of management.
- Analytical, statistical, personal organization, and problem-solving skills.
- Proficient computer skills.
- Ability to travel (25%+).
- Ability to maintain confidentiality.
Benefits
Comp & perks- Incentive plan eligibility
- Purpose-driven work supporting blood donation, research, and innovation
- Non-profit organization environment
- Ability to work in a hybrid arrangement
