Senior Manager, Product Quality Integrator

Johnson Johnson; Malvern (Chester County); On-site; USD 122,000 - 213,000; Full time

Benefits offered by this job

Vacation time

Sick time

Parental leave

Bereavement leave

Volunteer leave

Job summary

Johnson & Johnson is recruiting for a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics. The role can be located in Malvern, Springhouse, Horsham, PA or Titusville, NJ, with end-to-end quality accountability from Early Development through commercialization.

The ideal candidate will lead Global Quality strategy, oversee regulatory submissions, coordinate with CMC/VC teams, and drive quality integration across clinical, DS, DP, FF and devices for large molecule products.

Qualifications

• Bachelor's degree in a relevant field is required.
• Minimum of 8 years' experience in pharma/biotech industry.
• Knowledge of cGMP standards, policies and procedures is required.
• Flexible hours to accommodate US/EMEA/ASPAC schedules and up to 10% travel may be required.

Responsibilities

• Represents Global Quality on CMC and Value Chain Teams; acts as a liaison and single point of Global Quality contact.
• Ensures Quality stage gate deliverables are achieved and health authority submissions are reviewed/approved.
• Defines QA resources for global/local QA of assigned products and leads the QA integration teams across development through launch.
• Maintains quality throughout clinical, DS, DP, finished goods and device development through launch, including complaint trend investigations.

Skills

Quality management

cGMP knowledge

Cross-functional collaboration

Risk assessment

Regulatory submissions support

Education

Bachelor's degree in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree

Job description

Johnson & Johnson is recruiting for a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics. The role can be located in Malvern, Springhouse, Horsham, PA or Titusville, NJ, with end-to-end quality accountability from Early Development through commercialization.

The ideal candidate will lead Global Quality strategy, oversee regulatory submissions, coordinate with CMC/VC teams, and drive quality integration across clinical, DS, DP, FF and devices for large molecule products.