Manager, Supplier Quality, Drug Delivery Systems (DDS)

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Job Function:

Quality

Job Sub Function:

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for Manager, Supplier Quality, Drug Delivery Systems (DDS), to be located in either Malvern, PA; Horsham, PA; Raritan, NJ or Titusville, NJ.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Purpose:

The Manager, Supplier Quality, Drug Delivery Systems provides External Quality oversight for an assigned portfolio of suppliers of drug delivery system (DDS) components and devices used in combination products. This role manages day-to-day supplier relationships and partners with R&D, MSAT, Procurement, and internal manufacturing sites to execute supplier qualification, quality and specification agreements, audits, change control, investigations, risk assessments, and performance monitoring in support of compliant, high-quality products and a reliable supply chain. The Manager owns the resolution of supplier quality issues for assigned suppliers through root cause analysis and corrective actions, executes supplier risk mitigation plans, and supports continuous improvement at supplier sites. Complex, multi-site, or high-risk issues are escalated to Senior Management.

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

You will be responsible for:

• 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.
• Supports issues related to DDS suppliers under scope of responsibility. Escalates complex, multi-site, or high-risk issues (for example, those requiring L2, PAM, or QRB review) to Senior Management and ensures timely mitigation of the quality components of the escalation.

Qualifications/Requirements:

• A minimum of a Bachelor’s degree; preferred subjects include Science, Engineering, or technical areas.

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