Senior Manager, Quality Asset Management

Job Function

Quality

Quality Assurance

Professional

Schaffhausen, Switzerland

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
• Belgium and Ireland
  - Requisition Number: R-095461

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

• 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 projects and with key product decisions.
• Supports the business continuity process including VCT strategy and BCP projects.
• Reviews Proactive Product Quality Scans with the VCT and assures appropriate mitigating actions are defined there.
• Prepare quality sections of Product Strategy and End-to-end Value Chain Mapping.
• Participate in the F2F VCT meetings on PSR and VCM finalization and project prioritization.
• Align and interface the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.
• Presents project updates to QM for Global Quality alignment:
• Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions.
• Participates and actively engages on IMTs. Supports field/recalls as needed.
• Drives Decision making and Problem Solving:
• Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
• Gives input to the development of new strategies and implements and deploys strategies. Aids in the creation of product portfolio guidelines on the control strategy for new products which will influence the development strategy and the total…