About this role
<style type="text/css">table.MiTabla { max-width: 1020px;!important </style> <table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_16_CORP.jpg/cdab49ad-25d9-cb67-8db9-c818cbac0e62?t=1636640425166" alt="" align="top/"></td> </tr> <tr> <td> <p style="text-align:justify">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.</p> </td> </tr> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></td> </tr> </tbody> </table><p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong><u>Summary</u></strong>:</p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">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.</p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong><u>Primary Responsibilities</u></strong>:</p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong>Leadership & Strategic Direction</strong></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="circle"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Lead and develop a national Quality Operations team </li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Establish strategic priorities for Quality Operations aligned with corporate goals.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Ensure effective communication, collaboration, and alignment with Operations, Medical Affairs, Regulatory, and Quality counterparts.</li> </ul> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong>Compliance & Quality Oversight</strong></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="circle"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Ensure donor centers comply with US FDA, EMA, PPTA IQPP standards, CLIA/COLA, and state regulations.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Maintain audit and inspection readiness across all centers.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Oversee investigations, deviations, CAPAs, complaints, donor safety events, and product quality issues.</li> </ul> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong>Quality Management System (QMS)</strong></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="circle"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Oversee implementation and effectiveness of QMS elements at Donor Center level: Change Control, Document Management, CAPA, Training, Risk Management, Supplier Quality.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Ensure procedures are implemented consistently and updated according to regulatory or corporate requirements.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Support harmonization of quality processes across all donor centers.</li> </ul> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong>Product Quality & Operational Controls</strong></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="circle"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Ensure plasma collection, processing, labeling, storage, and shipment meet GMP and IQPP standards.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Monitor product quality trends</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Support product release, hold disposition, and quality decisions impacting customers.</li> </ul> </ul> <p style="margin:0.0in 0.0in 0.0in 0.25in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong>Performance Monitoring & Reporting</strong></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="circle"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Establish and track quality metrics, KPIs, dashboards, and trends for Donor Centers</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Communicate performance and risk indicators for Donor Centers to senior leadership.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Lead continuous improvement initiatives and process optimization for Donor Centers.</li> </ul> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong>Cross-Functional Collaboration</strong></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="circle"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Partner with Operations, Engineering, IT, Medical, Supply Chain, and Regulatory Affairs to ensure integrated, compliant processes at Donor Center level.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Support equipment qualification, calibration programs, system validation, and operational readiness for new technologies.</li> </ul> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong>Training, Coaching & Quality Culture</strong></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="circle"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Ensure ongoing training and competency development for Quality staff at Donor Centers level.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Promote a proactive quality mindset with strong ownership at Donor center level.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Lead initiatives to strengthen quality behavior and compliance across donor centers.</li> </ul> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong><u>Additional Responsibilities:</u></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong>Problem Solving</strong></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="circle"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Solves complex operational and compliance issues requiring interpretation of regulations, trend analysis, and cross-functional inputs.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Apply risk-based decision making and scientific reasoning to determine corrective actions, process improvements, and quality controls.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Able to anticipate and prevent quality risks across multiple centers.</li> </ul> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong>Decision-Making Authority</strong></li> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="circle"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Approves quality decisions affecting donor safety, product quality, and regulatory compliance.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Together with Quality Assurance Director, makes determinations on deviations, investigations, holds, CAPAs, and procedural adherence.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Escalates significant issues to VP US Plasma Quality & Medical and Quality Assurance Director, as needed.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Helps define strategic quality priorities for the plasma collection network.</li> </ul> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong><u>Knowledge, Skills, and Abilities:</u></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Deep knowledge of FDA/EMA/PPTA/WHO and applicable regulations or guidances.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Leadership and people development.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Proven success in driving cross-functional improvements.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Risk management and root-cause analysis.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Analytical and data-driven mindset.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Excellent communication, negotiation, and influencing skills.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Operational excellence and continuous improvement capability.</li> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong><u>Education and Experience</u></strong>:</p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Bachelor’s in Life Sciences, Pharmacy, Biology, Nursing or related field (required).</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Master’s degree preferred.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Typically requires 10 years in GxP or plasma/biologics Quality roles.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">5+ years leading multi-site Quality Operations teams.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Strong inspection management experience (FDA, EMA, PPTA, CLIA/COLA, State, internal audits).</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Experience with QMS systems (TrackWise, etc.).</li> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><strong><u>Occupational Demands</u></strong>:</p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Based at RTP headquarters, occasionally remote role with 40–60% travel to US plasma centers.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">May require off-hour availability to respond to critical quality events, inspections, or escalations.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif">Fast-paced, multi-site operational environment.</li> </ul> <p style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <p style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <p>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! </p> <p> </p> <p>#BiomatUSA</p> <p>#LI-RL1</p> <p>#LI-HYBRID</p><p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Third Party Agency and Recruiter Notice:</span></span></p> <p style="margin-bottom:11.0px"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">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.</span></span></p> <p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><strong><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">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.</span></span></strong></p> <p> </p> <p><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></p> <p><strong>Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters</strong> </p> <p> </p> <p><a href="https://www.grifols.com/en/what-we-do" target="_blank" rel="noopener">Learn more about Grifols</a></p> <p> </p>