SR Manager Product Quality Integrator

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Quality

Quality Assurance

Professional

Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Johnson & Johnson is currently recruiting for two Senior Manager, Product Quality Integrators! This position can be located in Malvern, Springhouse, Horsham, PA and Titusville, NJ. Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics. The position will be based at US sites

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

Learn more at  and follow us @Janssen Global.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The Senior Manager, Product Quality Integrator, Launch and Grow Biotherapeutics has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Launch and Grow for an assigned group of large molecules (biological) products.

• Represents Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams. Serves as liaison between VCT and Analytical group. Serves as the single point of Global Quality contact.
• Ensures Quality stage gate deliverables are achieved.
• Quality reviewer/approver of health authority submissions (i.e., IND, IMPD, BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Support PAI and agency audits for the product(s) assigned.
• Defines and oversees the necessary QA resource for global and local QA of his or her assigned products.
• Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, FF & device: development through launch.
• Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device:
• Ensures product quality development through Launch and Grow stage.
• Supports the sites, represents the sites on CMC and VC teams.
• Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
• Ensures patients get the right quality products
• Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.
• Manages preparation…