Senior Manager, Biotherapeutics Product Quality

Johnson & Johnson Innovative Medicine; Malvern (Chester County); In loco; USD 122.000 - 213.000; Tempo pieno

Vantaggi offerti da questo lavoro

Vacation –120 hours per calendar year

Sick time – 40 hours per calendar year

Holiday pay – 13 days per calendar yr

Work, Personal and Family Time – 40 h/

Descrizione del lavoro

Johnson & Johnson is recruiting for two Senior Manager, Product Quality Integrator roles for Launch & Grow Biotherapeutics. Locations include Malvern, Horsham, Titusville, and other US sites.

You will lead end-to-end quality strategy from Early Development through commercialization, guiding QA for large-molecule products. The role requires strong knowledge of cGMP, cross-functional leadership, and the ability to coordinate across global teams.

Competenze

• A minimum of 8 years’ experience in the pharmaceutical or biotechnology industry.
• Knowledge in cGMP standards, policies and procedures.
• Ability to work across organizational boundaries through presenting, influencing and partnering.
• Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary.
• Position located in Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, PA; or Chesterbrook, PA; up to 10% travel.

Mansioni

• Represents Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams; liaison between VCT and Analytical group.
• Ensures Quality stage gate deliverables are achieved.
• Quality reviewer/approver of health authority submissions (IND, IMPD, BLA, NDA, MAA) and related questions; supports audits.
• Defines and oversees QA resources for global and local QA of assigned products.
• Leads Quality integration teams for development through launch across clinical, DS, DP, FF & device.

Conoscenze

cGMP knowledge

Cross-functional collaboration

Regulatory submissions knowledge

Risk assessment

Communication

Formazione

Bachelor's degree in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering

Descrizione del lavoro

Johnson & Johnson is recruiting for two Senior Manager, Product Quality Integrator roles for Launch & Grow Biotherapeutics. Locations include Malvern, Horsham, Titusville, and other US sites.

You will lead end-to-end quality strategy from Early Development through commercialization, guiding QA for large-molecule products. The role requires strong knowledge of cGMP, cross-functional leadership, and the ability to coordinate across global teams.