Senior Manager, Quality Asset Management

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:
Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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 to be located in Titusville, NJ; Raritan, NJ; Malvern, PA or Spring House, PA.

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):


* Belgium - Requisition Number: R-095461


* 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.

Key Responsibilities:


* 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 com...