Senior Manager Product Quality Integrator

Gefunden in: beBee jobs CH - vor 1 Woche

Schaffhausen, Schaffhausen, Schweiz Johnson & Johnson Vollzeit
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Key Responsibilities
  • The Senior Manager, Product Quality Integrator has end-to-end accountability for the quality strategy and quality aspects for new products from Early Development through commercialization in Launch and Grow for an assigned portfolio of products.
  • Represents Global Quality on the CMC and Value Chain Team (VCT). Serves as liaison between VCT and Analytical group. Serves as the single point of Global Quality contact. Drives communication with all Q&C partners.
  • Ensures Quality achievements and Quality stage gate deliverables are achieved. Quality reviewer/approver of health authority submissions (i.e.,BLA, NDA, MAA) and associated HA questions on the filings. Support PAI and agency audits for the product assigned.
  • Defines and coordinates the vital QA resource for global and local QA of their assigned products.
  • Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device.
  • Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
  • Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.
  • Demonstrate knowledge of product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management.
  • Gives input to the development of new strategies. Implements and deploys strategies. Aids in the creation of product portfolio guidelines on the control strategy for development products which will influence the development strategy and the total quality cost during commercial production. These include decisions for Design for manufacturability, quality by design versus the cost of development, time to market.

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