Hybrid DDS Supplier Quality Manager

Regulatory Jobs; Malvern (Chester County); On-site; USD 105,000 - 182,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Supplier Quality for Drug Delivery Systems (DDS) to oversee External Quality for an assigned DDS supplier portfolio across Malvern, Horsham, Raritan, or Titusville. You will partner with R&D, MSAT, Procurement, and internal sites to drive supplier qualification and quality commitments.

The role focuses on root-cause analysis, corrective actions, risk mitigation, and continuous improvement to ensure compliant, high-quality products and a reliable supply

Qualifications

• Bachelor’s degree in science, engineering, or a related technical field.
• Minimum 6 years in medical devices, combination products, biologics, or related regulated environments.
• Experience with global cGMP, ISO 13485, FDA 21 CFR Part 820, and combo product requirements.

Responsibilities

• Manages external supplier quality relationships for DDS components and devices across multiple sites.
• Provides input on design specifications, materials sourcing, and compliance during design control with R&D teams.
• Executes supplier quality management activities including audits, change control, investigations, and risk assessments.
• Owns root-cause analysis and corrective actions for supplier quality issues; verifies effectiveness.
• Manages supplier risk, identifies high-risk processes, and tracks mitigation plans.
• Supports continuous improvement and quality culture at suppliers; escalates high-risk issues to leadership.

Skills

Problem-solving

Communication

External partner management

Regulatory knowledge

MS Office

Education

Bachelor’s degree in Science/Engineering/technical field

Tools

Quality Management System (QMS)

Documentation control systems

Job description

Johnson & Johnson is seeking a Manager, Supplier Quality for Drug Delivery Systems (DDS) to oversee External Quality for an assigned DDS supplier portfolio across Malvern, Horsham, Raritan, or Titusville. You will partner with R&D, MSAT, Procurement, and internal sites to drive supplier qualification and quality commitments.

The role focuses on root-cause analysis, corrective actions, risk mitigation, and continuous improvement to ensure compliant, high-quality products and a reliable supply