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JOB SUMMARY

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

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, 3 rd -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.

ESSENTIAL FUNCTIONS OF THE ROLE

+ Assists 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.

+ Supports and ensures quality assurance in all aspects of operations for the CT / BMT Program.

+ Provides quality/regulatory guidance to CT / BMT Program departments as needed (Processing Laboratory, Apheresis Unit, Inpatient and Outpatient Clinical Units).

+ Monitors processes and regulatory compliance to meet FACT, FDA, IRB, 3 rd -Party Manufacturers and other regulatory agencies requirements.

+ Assists in external audits/inspections including preparation, hosting, developing written responses and corrective action plans regarding recommendations.

+ Maintains continuous readiness for planned, random and/or unannounced surveys.

+ Conducts regular and ad hoc internal audits as assigned

+ Assists with equipment, software, and process validation planning, execution, and summation.

+ Maintains knowledge of quality assurance requirements, systems, methods, and best practices through training and self-study.

+ Develops, revises, and manages CT / BMT Program standard operating procedures (SOPs), policies, and documentation.

+ Facilitates, coordinates, and provides project management for quality improvement projects

+ Maintains 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.

+ Participate in special projects as assigned

KEY SUCCESS FACTORS

+ Knowledge of FACT Standards

+ Knowledge of FDA GLP/GCP/GMP/GTP regulations

+ Knowledge of FDA 21 CFR Part 1271

+ Knowledge of equipment, software and process validation.

+ Skilled in the use of computers, and related software applications

+ Exceptional verbal, social and written communication skills

+ Able to work collaboratively and effectively with a wide range of stakeholders, and across organizational lines and teams

+ Able to identify and deploy required project management processes, tools, and templates needed to successfully drive initiatives

+ Able to partner with key stakeholders to identify impediments to success and recommend and implement corrective actions and/or mitigation

+ Able to work alone or with varying levels of direct or indirect supervision and guidance

+ Able to appropriately prioritize tasks to meet desired deadline

+ Certified Professional in Healthcare Quality (CPHQ), Certified Advanced Biotherapies Professional (CABP), or role-appropriate certification preferred

+ Licensure such as Registered Nurse (RN), Medical Technologist (MT) / Medical Laboratory Scientist (MLS), etc. preferred.

BENEFITS

Our competitive benefits package includes the following

+ Immediate eligibility for health and welfare benefits

+ 401(k) savings plan with dollar-for-dollar match up to 5%

+ Tuition Reimbursement

+ PTO accrual beginning Day 1

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

QUALIFICATIONS

+ EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification

+ EXPERIENCE - 4 Years of Experience

As a health care system committed to improving the health of those we serve, we are asking our employees to model the same behaviours that we promote to our patients. As of January 1, 2012, Baylor Scott & White Health no longer hires individuals who use nicotine products. We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.