Quality Risk Specialist

GRIFOLS, S.A.•NC-RTP, CA

2d•Onsite

About The Position

Drives and rigorously evaluates activities that uphold and enforce organizational compliance with corporate quality standards and regulatory requirements. This includes leading comprehensive Quality Management System (QMS) reviews, managing deviations, executing robust data integrity assessments, and conducting thorough risk management evaluations. The role plays a critical part in ensuring sustained compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and Grifols Quality Systems by proactively analyzing, interpreting, and monitoring quality data, key metrics, and associated systems.

Requirements

Excellent problem solving, analytical and communication skills (i.e., verbal, written, and electronic).
Working knowledge of plasma centers, plasma receiving facilities and testing labs and associated data systems (DMS, LMS, etc).
Experience using the principles of Statistical Process Control, Six Sigma, Lean or similar, to evaluate data and drive process improvement.
Ability to successfully interface with all levels of management and customers or suppliers in various functions to ensure well documented, factually supported analyses of issues related to supplier, test lab, warehouse logistics and plasma platform quality.
Ability to craft meaningful reports to communicate process deficiencies and improvement opportunities to varied levels of the operations from center personnel to executive summaries.
Knowledge of all customer and regulatory body requirements, including State and Federal regulations, European Union (EU) requirements, Occupational Safety and Health Administration (OSHA) regulations and the Clinical Laboratory Improvement Act of 1988 ("CLIA"), etc.
Experience in CAPA and Quality Management techniques.
Conflict resolution skills including persuasive management techniques required.
Excellent interpersonal skills required.
The incumbent must have the ability to write clear, concise, logical responses to regulatory authorities.
Must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma.
Must know the European Pharmacopoeia (EP) and other European Guidelines as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s).
Must have strong interpersonal skills with the ability to communicate effectively, both written and verbal, with persons from other cultures and other points of view.
Bachelor's degree required.
Minimum 5 years of experience in the quality assurance related field.

Nice To Haves

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Responsibilities

Executes rigorous evaluations of quality systems to verify and enforce full compliance with all applicable internal and external regulations and standards.
Champions data integrity and risk management initiatives by executing thorough, methodical assessments that identify vulnerabilities and drive targeted mitigation actions. Conducts comprehensive evaluations of data derived from equipment, computerized systems, software, and all processes that generate, process, or store GxP data within Plasma Procurement, ensuring robust control and uncompromised data reliability.
Critically evaluates quality metrics and emerging trends to pinpoint operational weaknesses and drive meaningful organizational improvement. Responsibilities include the precise processing, interpretation, and integration of monthly QUINTET reports and KPI dashboard data to inform data‑driven decision‑making.
Leads the development and critical review of Quality Risk Assessments while driving seamless coordination with donor centers, Field Quality, and cross‑functional partners to ensure alignment, clarity, and timely execution.
Performs disciplined data integrity evaluations, identifying vulnerabilities, detecting systemic trends, and driving timely mitigation measures.
Drives cross‑functional collaboration to strengthen and continuously elevate quality systems by proactively identifying risks and implementing effective mitigation strategies.
Critically evaluates audit findings to identify improvement opportunities and delivers targeted, actionable solutions that strengthen compliance with Domestic and EU regulations, Standard Operating Procedures (SOPs), and customer requirements.
Proactively evaluates operational and regulatory drivers for change, initiating Change Requests and authoring robust Standard Operating Procedures in response to identified trends, audit insights, and facility interactions.
Conducts comprehensive evaluations of Corporate and Donor Center deviations, rigorously analyzing tracking and trending data to drive continuous improvement and reinforce a culture of accountability and quality excellence.
Authors comprehensive Deviation Reports, CAPAs, and Effectiveness Checks that address corporate findings and other identified deficiencies, ensuring clear justification, robust corrective actions, and sustained compliance.
Serves as a key departmental representative in company‑wide initiatives, ensuring unwavering adherence to regulatory requirements, Standard Operating Procedures (SOPs), and customer expectations.