On-Floor QA Leader: Cell Therapy Operations

Catalent; Princeton (NJ); Presencial; USD 130.000 - 160.000; Jornada completa

Descripción de la vacante

Catalent, based in Princeton, NJ, seeks a Manager, Quality Assurance Operations to provide on-the-floor QA oversight for GMP cell therapy manufacturing. The role includes batch record review, lot disposition, deviation management, and collaboration with Manufacturing, Supply Chain, and Regulatory Affairs.

Requirements include a Bachelor’s in Science/Engineering, 7+ years in GMP environments, and 3+ years of leadership experience. On-site position with a competitive salary in New Jersey.

Formación

• Bachelor’s degree in Science or Engineering is required; advanced degree preferred.
• Minimum 7 years in GMP pharmaceutical/biologics manufacturing with QA on-the-floor experience.
• At least 3 years in a leadership or supervisory role; coaching capability required.
• 5+ years QA experience supporting manufacturing operations and on-the-floor quality activities.
• Familiarity with regulatory standards (21 CFR 210/211, biologics, EU GMPs, ICH).

Responsabilidades

• Provide real-time QA on-the-floor support for cell therapy manufacturing operations.
• Perform GMP walkthroughs and ensure GDP compliance in processing areas.
• Review batch records and assist in lot disposition and release decisions.
• Review and approve deviations, nonconformances, CAPAs, and change controls.
• Support supplier qualification activities and material investigations.
• Assist in regulatory inspections and cross-functional QA guidance.

Conocimientos

QA oversight

GMP knowledge

Batch record review

Deviation management

Change control

Leadership

Cross-functional

Supplier qualification

Educación

Bachelor's degree in Science/Engineering

Advanced degree preferred

Descripción del empleo

Catalent, based in Princeton, NJ, seeks a Manager, Quality Assurance Operations to provide on-the-floor QA oversight for GMP cell therapy manufacturing. The role includes batch record review, lot disposition, deviation management, and collaboration with Manufacturing, Supply Chain, and Regulatory Affairs.

Requirements include a Bachelor’s in Science/Engineering, 7+ years in GMP environments, and 3+ years of leadership experience. On-site position with a competitive salary in New Jersey.