Joseph Bell
Winston-Salem
Summary
A results-driven leader passionate about building a culture of quality where training is the foundation of operational success. I believe in a "Right the First Time" approach, ensuring compliance and efficiency through proactive training, continuous improvement, and risk-based decision-making. With a strong background in GxP compliance, quality systems, and regulatory oversight, I specialize in developing high-impact training programs that empower teams to uphold the highest industry standards. By fostering collaboration, driving accountability, and embedding a quality-first mindset across all levels of an organization, I help teams achieve operational excellence while reducing risk and ensuring inspection readiness.
Overview
9
9
years of professional experience
Work History
Director of GxP Training and Compliance
ProKidney
07.2023 - Current
- Lead the development and execution of GxP training programs, ensuring compliance with FDA, EMA, and other regulatory requirements
- Oversee training administration in MasterControl LMS, managing user roles, job codes, and qualification tracking
- Collaborate with cross-functional departments to align training programs with GMP, GCP, and GDP standards
- Develop and implement training effectiveness metrics, analyzing trends to improve compliance and competency
- Spearhead training standardization initiatives across GMP and GCP departments to enhance consistency and regulatory adherence
- Provide leadership and mentorship to training specialists, fostering a quality-first culture with a 'right the first time' mindset
- Support internal audits and regulatory inspections by ensuring training records are complete, accurate, and audit-ready
Director of Regulatory Affairs and Quality Assurance
Miracles In Sight
02.2022 - 06.2023
- Developed and implemented the Quality Assurance program, ensuring compliance with regulatory standards and passing all regulatory audits through the implementation of a program based on the principles of Total Quality Management and Six Sigma
- Managed the preparation and submission of regulatory documents
- Provided regulatory guidance and support to cross-functional teams, including R&D, Quality, Clinical Affairs, and Process Development
- Maintained current knowledge of relevant regulations, guidelines, and standards, and ensured compliance with all applicable requirements
- Developed and maintained positive relationships with regulatory agencies and industry organizations
- Managed and oversaw regulatory affairs staff, using leadership and interpersonal skills to ensure compliance with all regulations by improving processes and procedures, delivering results with an emphasis on quality
Quality Manager
Takeda Pharmaceuticals
08.2017 - 01.2021
- Successful opening of the fastest growing center in company history to date
- Traveled throughout the US to aid in the opening, organizing, and inspections of new facilities
- Passed all new laboratory inspections including FDA, EMA, CLIA, PPTA, and State Health Department
- Created and presented to the entire network a 'How to: Cognos' guide to show step-by-step instruction on building metric reports, setting up email schedules
- Tracked and trended long-term errors and created situational reports for the Global Event Management system, Medical Affairs, and regulatory inspections
- Was a Six Sigma yellow belt, part of the continuous improvement team made up of quality and operation management
- Applied the DMAIC improvement cycle to areas of opportunity throughout the facilities in my region
- Served as a network SME for investigating and developing effective CAPAs
- Managed the training department to create a 'right first time' workplace
AP Biology Teacher
George Jenkins High School
08.2016 - 05.2017
- Designed and facilitated AP Biology curriculum to ensure mastery of major concepts, resulting in 90% of the class achieving a score of 4 or 5 on the AP Bio exam
- Developed activities and presentations to enhance student understanding of key topics, supported independent study enabling students to develop and communicate scientific knowledge
- Conducted Masters-level research in conjunction with the University of South Florida on teaching controversial topics
Education
Master of Studies in Law - International Compliance
Wake Forest University School of Law
Winston-Salem, NC01.2024
Bachelor of Arts - Biology and Secondary Science Education
University of South Florida
Tampa, FL01.2018
Skills
- Quality Management Systems (QMS)
- Expertise in FDA, EMA, Eudralex, ICH-GCP, GDP, GMP, and GLP regulations
- Risk-Based Monitoring (RBM)
- Audit and Inspection Readiness
- Root Cause Analysis (RCA)
- Lean Six Sigma/ Continuous Improvement
- Curriculum Development
- GxP LMS Administration
- Corporate Trainer: GDocP, Ethics, GMP, GCP, Cleanroom behaviour, Deviation, CAPA, Change Control, Aseptic Processing, and more
Affiliations
- Vice Chair - American Society for Quality (ASQ) North Carolina Chapter
- Marketing Chair - Little Theatre of Winston Salem Board of Directors
Timeline
Director of GxP Training and Compliance
ProKidney
07.2023 - Current
Director of Regulatory Affairs and Quality Assurance
Miracles In Sight
02.2022 - 06.2023
Quality Manager
Takeda Pharmaceuticals
08.2017 - 01.2021
AP Biology Teacher
George Jenkins High School
08.2016 - 05.2017
Bachelor of Arts - Biology and Secondary Science Education
University of South Florida
Master of Studies in Law - International Compliance
Wake Forest University School of Law
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