Senior Manager, Quality Asset Management

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Brussels, Brussels-Capital Region, Belgium Job Description: Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a  Senior Manager, Quality Asset Management within Advanced Therapies. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-094866 Switzerland – Requisition Number: R-095456 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. The Senior Manager, Quality Asset Management has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Advanced Therapies 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 product lifecycle. 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 of the PPQS in advance of Review Board and Executive Management Review. Supports preparation of the criticality analysis per schedule. Ensures complaints are well managed, issues are understood, and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics. Coordinates and/or owner of complaints trend signal investigations. Partners with Product Quality Owner (PQO) Value Optimize & Late Stage to complete Transfer of Ownership activities. Represents Global Quality on the Value Chain Teams (VCT): Maintains the flow of communications between Global Quality and VCT teams. Brings Quality issues to the VCT and assists with prioritization of