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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Summary
The Director of Quality Operations ensures that all plasma donor centers in the United States consistently operate in full compliance with FDA and PPTA regulations, corporate quality standards, and industry best practices. The role provides strategic and operational leadership of Quality Operations across all centers, overseeing the deployment and continuous optimization of the Quality Management System (QMS), product quality, donor safety, and regulatory readiness while fostering a strong quality culture across the organization.
Primary Responsibilities
Leadership & Strategic DirectionLead and develop a national Quality Operations team Establish strategic priorities for Quality Operations aligned with corporate goals.Ensure effective communication, collaboration, and alignment with Operations, Medical Affairs, Regulatory, and Quality counterparts.Compliance & Quality OversightEnsure donor centers comply with US FDA, EMA, PPTA IQPP standards, CLIA/COLA, and state regulations.Maintain audit and inspection readiness across all centers.Oversee investigations, deviations, CAPAs, complaints, donor safety events, and product quality issues.Quality Management System (QMS)Oversee implementation and effectiveness of QMS elements at Donor Center level: Change Control, Document Management, CAPA, Training, Risk Management, Supplier Quality.Ensure procedures are implemented consistently and updated according to regulatory or corporate requirements.Support harmonization of quality processes across all donor centers.Product Quality & Operational ControlsEnsure plasma collection, processing, labeling, storage, and shipment meet GMP and IQPP standards.Monitor product quality trendsSupport product release, hold disposition, and quality decisions impacting customers.Performance Monitoring & ReportingEstablish and track quality metrics, KPIs, dashboards, and trends for Donor CentersCommunicate performance and risk indicators for Donor Centers to senior leadership.Lead continuous improvement initiatives and process optimization for Donor Centers.Cross-Functional Collaboration
- Partner with Operations, Engineering, IT, Medical, Supply Chain, and Regulatory Affairs to ensure integrated, compliant processes at Donor Center level.
- Support equipment qualification, calibration programs, system validation, and operational readiness for new technologies.
- Training, Coaching & Quality Culture
- Ensure ongoing training and competency development for Quality staff at Donor Centers level.
- Promote a proactive quality mindset with strong ownership at Donor center level.
- Lead initiatives to strengthen quality behavior and compliance across donor centers.
Additional Responsibilities
Problem Solving
- Solves complex operational and compliance issues requiring interpretation of regulations, trend analysis, and cross-functional inputs.
- Apply risk-based decision making and scientific reasoning to determine corrective actions, process improvements, and quality controls.
- Able to anticipate and prevent quality risks across multiple centers.
- Decision-Making Authority
- Approves quality decisions affecting donor safety, product quality, and regulatory compliance.
- Together with Quality Assurance Director, makes determinations on deviations, investigations, holds, CAPAs, and procedural adherence.
- Escalates significant issues to VP US Plasma Quality & Medical and Quality Assurance Director, as needed.
- Helps define strategic quality priorities for the plasma collection network.
Knowledge, Skills, And Abilities
- Deep knowledge of FDA/EMA/PPTA/WHO and applicable regulations or guidances.
- Leadership and people development.
- Proven success in driving cross-functional improvements.
- Risk management and root-cause analysis.
- Analytical and data-driven mindset.
- Excellent communication, negotiation, and influencing skills.
- Operational excellence and continuous improvement capability.
Education And Experience
- Bachelor’s in Life Sciences, Pharmacy, Biology, Nursing or related field (required).
- Master’s degree preferred.
- Typically requires 10 years in GxP or plasma/biologics Quality roles.
- 5+ years leading multi-site Quality Operations teams.
- Strong inspection management experience (FDA, EMA, PPTA, CLIA/COLA, State, internal audits).
- Experience with QMS systems (TrackWise, etc.).
Occupational Demands
- Based at RTP headquarters, occasionally remote role with 40–60% travel to US plasma centers.
- May require off-hour availability to respond to critical quality events, inspections, or escalations.
- Fast-paced, multi-site operational environment.
This position is eligible to participate in up to 30% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!
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Third Party Agency And Recruiter Notice
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters
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