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, 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.
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, 3rd-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