JOB SUMMARY

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Hybrid position in Dallas, TX (usual schedule is two days onsite & three days from home)

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The Cellular Therapy (CT) / Bone Marrow Transplant (BMT) Quality Consultant plays a central role in ensuring the Baylor University Medical Center (BUMC) CT / BMT Program maintains compliance with Foundation for the Accreditation of Cellular Therapy (FACT) standards, Food and Drug Administration (FDA) regulations, Institutional Review Board (IRB) requirements, 3rd-Party Manufacturers’ requirements,  and other regulatory requirements. The consultant will serve as a subject matter expert on FACT standards, liaise with multidisciplinary stakeholders, and drive a culture of excellence in the CT / BMT Quality Program.

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 ESSENTIAL FUNCTIONS OF THE ROLE

\n\nAssists the Manager of Quality Assurance and Regulatory Affairs in the management of the CT / BMT Program quality program, including document management, quality audits, training compliance, occurrence management, and continuous quality improvement (CQI) initiatives. \nSupports and ensures quality assurance in all aspects of operations for the CT / BMT Program. \nProvides quality/regulatory guidance to CT / BMT Program departments as needed (Processing Laboratory, Apheresis Unit, Inpatient and Outpatient Clinical Units).\nMonitors processes and regulatory compliance to meet FACT, FDA, IRB, 3rd-Party Manufacturers and other regulatory agencies requirements. \nAssists in external audits/inspections including preparation, hosting, developing written responses and corrective action plans regarding recommendations. \nMaintains continuous readiness for planned, random and/or unannounced surveys.\nConducts regular and ad hoc internal audits as assigned \nAssists with equipment, software, and process validation planning, execution, and summation.\nMaintains knowledge of quality assurance requirements, systems, methods, and best practices through training and self-study.\nDevelops, revises, and manages CT / BMT Program standard operating procedures (SOPs), policies, and documentation.\nFacilitates, coordinates, and provides project management for quality improvement projects\nMaintains awareness of the latest developments, advancements, and trends in the field of CT / BMT and quality by attending seminars/workshops, reading professional journals, and active participation in professional organizations.\nParticipate in special projects as assigned\n\n

 KEY SUCCESS FACTORS

\n\nKnowledge of FACT Standards\nKnowledge of FDA GLP/GCP/GMP/GTP regulations\nKnowledge of FDA 21 CFR Part 1271\nKnowledge of equipment, software and process validation. \nSkilled in the use of computers, and related software applications\nExceptional verbal, social and written communication skills\nAble to work collaboratively and effectively with a wide range of stakeholders, and across organizational lines and teams\nAble to identify and deploy required project management processes, tools, and templates needed to successfully drive initiatives\nAble to partner with key stakeholders to identify impediments to success and recommend and implement corrective actions and/or mitigation\nAble to work alone or with varying levels of direct or indirect supervision and guidance\nAble to appropriately prioritize tasks to meet desired deadline\nCertified Professional in Healthcare Quality (CPHQ), Certified Advanced Biotherapies Professional (CABP), or role-appropriate certification preferred\nLicensure such as Registered Nurse (RN), Medical Technologist (MT) / Medical Laboratory Scientist (MLS), etc. preferred.\n\n

BENEFITS

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Our competitive benefits package includes the following

\n\nImmediate eligibility for health and welfare benefits\n401(k) savings plan with dollar-for-dollar match up to 5%\nTuition Reimbursement\nPTO accrual beginning Day 1\n\n

Note: Benefits may vary based on position type and/or level

QUALIFICATIONS

\n\n\n\tEDUCATION - Bachelor's or 4 years of work experience above the minimum qualification\n\tEXPERIENCE - 4 Years of Experience\n