SR Manager Product Quality Integrator (2 openings)

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
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

Job Description:

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 www.janssen.com and follow us @JanssenGlobal.

We are Janssen.

Our mission drives us.

Our patients inspire us.

We collaborate with the world for the health of everyone in it.

Position Summary:

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.

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) ...