DDS Supplier Quality Manager — External Quality Leader

Johnson & Johnson Co.; Horsham (PA); Presencial; USD 105.000 - 182.000; Jornada completa

Descripción de la vacante

Johnson & Johnson is seeking a Manager, Supplier Quality, Drug Delivery Systems (DDS) to oversee External Quality for a portfolio of DDS suppliers in the US. This role partners with R&D, MSAT, Procurement and manufacturing to execute supplier qualification, quality and specification agreements, audits, change control and investigations.

You will lead root cause analyses, corrective actions, and supplier risk mitigation, driving continuous improvement across sites while maintaining strong

Formación

• Bachelor’s degree required; Science/Engineering preferred.
• Minimum 6 years in medical devices, combination products, or regulated environments.
• Knowledge of global cGMP, ISO 13485, FDA 21 CFR Part 820 and regulatory requirements for combination products.
• Experience designing or qualifying device components or combination product design and commercialization.
• Experience managing external partners or suppliers.
• Strong problem-solving and ability to manage complexity within a supplier portfolio.
• Excellent verbal and written communication with internal and external stakeholders.
• Proficiency in MS Office tools.

Responsabilidades

• Manage external supplier relationships and provide External Quality oversight for DDS components and devices.
• Partner with R&D/Quality design teams on design specs, material sourcing, and compliance in design control.
• Collaborate with multiple stakeholders to perform quality activities: audits, specifications, change control, investigations, risk assessments, and performance reviews.
• Own supplier quality issue resolution from root cause to corrective actions and verification.
• Lead supplier risk management and cross-site mitigation plans, escalating when needed.
• Foster a proactive quality culture and continuous improvement at suppliers.

Conocimientos

Communication

Problem solving

Cross-functional collaboration

Analytical thinking

MS Office proficiency

Educación

Bachelor’s degree in Science/Engineering

Herramientas

MS Office

Descripción del empleo

Johnson & Johnson is seeking a Manager, Supplier Quality, Drug Delivery Systems (DDS) to oversee External Quality for a portfolio of DDS suppliers in the US. This role partners with R&D, MSAT, Procurement and manufacturing to execute supplier qualification, quality and specification agreements, audits, change control and investigations.

You will lead root cause analyses, corrective actions, and supplier risk mitigation, driving continuous improvement across sites while maintaining strong