DDS Supplier Quality Manager — Drug Delivery Systems

Johnson & Johnson Co.; Malvern (Chester County); Hybrid; USD 105,000 - 182,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Supplier Quality for Drug Delivery Systems to oversee External Quality for a portfolio of DDS suppliers. Location options include Malvern, Horsham, Raritan, or Titusville, with a hybrid work model.

You will collaborate with R&D, MSAT, Procurement, and internal manufacturing to qualify suppliers, draft quality and specification agreements, perform audits, change controls, investigations, and risk assessments to ensure compliant, high-quality products and a

Qualifications

• A minimum of a Bachelor’s degree; preferred subjects include Science, Engineering, or technical areas.
• A minimum of 6 years’ experience in medical devices, combination products, biologics, drug products, drug substance, or a similar regulated environment; some experience in Quality and Compliance preferred.
• Working knowledge of global cGMP requirements, ISO 13485, FDA 21 CFR Part 820, and regulatory requirements for combination product development.
• Experience and knowledge in device component design and/or combination product design and commercialization.
• Demonstrated experience managing external business partners or suppliers.
• Demonstrated problem-solving skills and the ability to manage complexity within an assigned supplier portfolio.
• Excellent verbal and written communication skills, including the ability to communicate effectively with internal and external partners.
• Excellent computer proficiency, for example MS Office.
• Preferred: Experience with primary containers and medical devices.
• Experience with plastics injection/extrusion molding, device assembly manufacturing, and sterilization.

Responsibilities

• Manages supplier relationships and provides External Quality oversight for an assigned portfolio of suppliers of Drug Delivery System (DDS) components and devices of combination products to support quality, compliant products and supply chain reliability.
• Partners with Research & Development (R&D) technical and quality design teams to provide supplier and manufacturing quality input on design specifications, material sourcing, and compliance considerations during design control.
• Partners with R&D, MSAT, Procurement, Internal IMSC sites, and other DDS development stakeholders to execute Supplier Quality Management activities for assigned suppliers, including quality agreements, specification agreements, audits, supply chain identification, qualification, change control, investigations, risk assessments, review of performance monitoring metrics, and complaints.
• Owns the resolution of supplier quality issues for assigned suppliers. This includes working with suppliers and internal stakeholders to perform root cause analysis and failure investigations, implementing corrective actions, and verifying effectiveness.
• Executes supplier risk management for assigned suppliers. This includes working with suppliers to identify high-risk process areas, implementing and monitoring risk mitigation plans, contributing to supplier risk management projects, and escalating risks that need leadership decisions or cross-site alignment.
• Supports a proactive quality culture and continuous improvement at assigned suppliers. This includes working with suppliers to identify sources of process variation, implementing process controls to improve capability, and applying best practices.

Skills

Supplier management

Quality systems

Root cause analysis

Regulatory knowledge

Communication

Education

Bachelor's degree in Science/Engineering/technical

Tools

MS Office

Job description

Johnson & Johnson is seeking a Manager, Supplier Quality for Drug Delivery Systems to oversee External Quality for a portfolio of DDS suppliers. Location options include Malvern, Horsham, Raritan, or Titusville, with a hybrid work model.

You will collaborate with R&D, MSAT, Procurement, and internal manufacturing to qualify suppliers, draft quality and specification agreements, perform audits, change controls, investigations, and risk assessments to ensure compliant, high-quality products and a