Grifols · 2 months ago
Clinical Quality Assurance (CQA) Quality Control & Process Specialist
North Carolina, United States
Full-time
Onsite
Senior Level
5+ years expGrifols is a global healthcare company dedicated to improving health and well-being since 1909. They are seeking a Clinical Quality Assurance (CQA) Quality Control & Process Specialist to participate in the development and review of clinical SOPs, provide quality oversight on clinical studies, and manage vendor qualifications.
BiotechnologyHealth CareManufacturing
Responsibilities
Participate in the development and review of the Clinical SOPs, Regulatory documents and Study Plans
Participate in the Clinical SOPs periodic reviews as well as in the creation of new procedures
Participate in the study plans reviews
Participate in the review of Regulatory Documents (Clinical Study Protocol, Investigators Brochure, Informed Consent Form, Clinica Study Report)
Provide quality oversight on the conduct of the clinical studies
Perform periodic quality reviews of the critical clinical procedures on the different clinical studies
Interact with Drug Development department to provide guidance and consultancy to resolve compliance issues
Coordinate the management of study, internal and vendor deviations
Participate in the review of critical protocol deviations and Serious Breaches
Participate in project team internal meetings providing information about quality metrics of studies
Collaborate in the development of the Quality Risk Management Assessment of the different clinical studies
Initiate the Quality Risk Assessment for every clinical study
Qualification and periodic assessment of clinical and pharmacovigilance vendors participating in the clinical studies
Perform a quality assessment (including a risk assessment) of all the vendors selected as candidates to participate in the clinical studies
Qualify the clinical vendors before their participation in the clinical studies and re-qualify them when applicable
Perform an annual assessment of the performance and compliance of the vendors participating in the clinical studies
Qualification
Required
Life Sciences Degree
A minimum of 5 years in a similar role or provide experience in Quality and Clinical Trials
Ability and willingness to travel
Ability to work both in a team and independently
Ability to meet deadlines, multitasks, and prioritize based on study needs
Ability to works on assignments with a diverse scope
Ability to work with a very limited direct supervision
Advanced knowledge of ICH/GCP Guideline
Advanced knowledge of electronic data capture (EDC) systems
Advanced knowledge of medical terminology
Advanced knowledge of the therapeutic areas assigned
Routinely demonstrates mastery of technical skills
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
2025-11-19
Company data provided by crunchbase