Quality Excellence Architect, North America

Regulatory Jobs; Franklin Lakes (NJ); Presencial; USD 169.000 - 270.000; Jornada completa

Descripción de la vacante

BD is seeking a Quality Excellence Capability Partner, North America, to design, deploy, and sustain technical quality training programs across North America. You will lead the Quality Excellence Academy, partnering with site Quality leaders and SMEs to close capability gaps while driving improved inspection readiness and quality culture.

This role requires 5+ years in regulated quality environments, with expertise in CAPA, change control, and learning delivery (instructor-led, virtual,

Formación

• Bachelor’s degree in Life Sciences, Sciences, Engineering or related field.
• 5+ years of experience in a medical device, pharmaceutical or biologics setting (e.g. FDA, ICH).
• Demonstrated expertise in Quality Engineering and Quality Systems within a regulated industry, including improving product and process performance.
• Experience delivering Quality or technical training in regulated settings (instructor-led, virtual, blended).
• Working knowledge of CAPA, nonconformance management, change control, process validation, design controls, and risk management.
• Experience coaching associates, SMEs, and leaders to strengthen capability and compliant behaviors.
• Ability to deliver training in English and Spanish.

Responsabilidades

• Lead deployment of the Quality Excellence Academy across North America.
• Develop and deliver instructor‑led, virtual, and blended learning programs.
• Translate quality requirements and best practices into practical learning solutions.
• Assess capability gaps and develop structured learning pathways and curricula.
• Serve as regional lead for Investigation Management, RCA, and Problem Solving.
• Expand programs into additional quality domains and ensure adoption of standard methodologies.

Conocimientos

Quality engineering

Quality systems

CAPA

Change control

Problem solving

Cross‑functional collaboration

Educación

Bachelor’s degree in Life Sciences, Sciences, Engineering or related field

Descripción del empleo

BD is seeking a Quality Excellence Capability Partner, North America, to design, deploy, and sustain technical quality training programs across North America. You will lead the Quality Excellence Academy, partnering with site Quality leaders and SMEs to close capability gaps while driving improved inspection readiness and quality culture.

This role requires 5+ years in regulated quality environments, with expertise in CAPA, change control, and learning delivery (instructor-led, virtual,