Sr Mgr Product Quality Integrator

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Leiden, South Holland, Netherlands, Little Island, Cork, Ireland, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland

Job Description:

Johnson & Johnson Innovative Medicine (J&J IM) is recruiting for a Senior Manager, Product Quality Integrator, Quality Asset Management Biotherapeutics.

The position will be based at our European sites

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

Main responsibilities include but are not limited to:


* 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, device and packaging: development through launch and commercial lifecycle.


* Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, device and packaging;


* 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 standard Global Quality processes (PPQS, CA, PRA, Complaints, Escalations) are used across sites and facilitates communication...