Senior Manager, Quality Asset Management

Senior Manager, Quality Asset Management

Aug 24, 2026

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

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

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 comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device:

Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.

Represents Global Quality on the Value Chain Teams (VCT):

Presents project updates to QM for Global Quality alignment:

Drives Decision making and Problem Solving:

Qualifications

Required

A minimum of a bachelor’s degree with a major or concentration in one of the following: Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree concentration

A minimum of 8 years’ experience in the pharmaceutical, or biotechnology industry

Knowledge of cGMP standards, policies and procedures

Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering

Ability to quickly assimilate new technologies, perform risk assessments and develop action plans

Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary, balancing work and personal time is required

This position may require up to 10% of domestic and international travel as business demands

Preferred

A Master’s degree or other advanced degree

Knowledge of biotech, vaccine, and/or sterile pharmaceutical manufacturing

Experience in technology transfer, process development and/or process validation

In-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies

Experience with developing and responding to quality content of regulatory filings, inspections, and preparedness activities

Experience in API and Drug Product stability

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual ori