Senior Product Quality Integrator – Biologics Launch Lead

6046-JANSSEN SUPPLY GROUP, LLC. Legal Entity; Malvern (Chester County); In loco; USD 122.000 - 213.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson seeks a Senior Manager, Product Quality Integrator, Launch and Grow Biotherapeutics to own quality strategy from Early Development through commercialization for large molecule products. You will lead global quality activities, coordinate with CMC and Value Chain teams, and ensure readiness for regulatory submissions.

The role requires 8+ years in pharma/biotech, strong knowledge of cGMP, and flexibility to travel.

Competenze

• A minimum of 8 years’ experience in the pharmaceutical or biotechnology industry.
• Knowledge in cGMP standards, policies and procedures.
• Ability to quickly assimilate new technologies, perform risk assessment and develop action plans.
• Flexible hours to accommodate US, EMEA and ASPAC work schedules.
• Location: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, PA; or Chesterbrook, PA; up to 10% travel.

Mansioni

• Represent Global Quality on the CMC and VCT teams.
• Liaise between VCT and Analytical group.
• Be the single Global Quality contact for assigned products.
• Ensure Quality stage gate deliverables are achieved.
• Review quality content for regulatory filings (IND, IMPD, BLA, NDA, MAA).
• Lead QA resources for global and local QA of assigned products.
• Oversee QA during development through Launch and Grow stages.
• Support field/recalls as needed.
• Drive quality decisions with cross-functional teams.

Conoscenze

Cross-functional collaboration

Risk assessment

Action planning

Formazione

Bachelor’s degree in Pharmacy/Biology/Biochemistry/Biotechnology/Engineering

Master’s degree preferred

Descrizione del lavoro

Johnson & Johnson seeks a Senior Manager, Product Quality Integrator, Launch and Grow Biotherapeutics to own quality strategy from Early Development through commercialization for large molecule products. You will lead global quality activities, coordinate with CMC and Value Chain teams, and ensure readiness for regulatory submissions.

The role requires 8+ years in pharma/biotech, strong knowledge of cGMP, and flexibility to travel.