SR Manager Product Quality Integrator (2 openings)

Johnson & Johnson seeks a Senior Manager, Product Quality Integrator for biotherapeutics in Launch and Grow stage, responsible for end-to-end quality strategy across development through commercialization. The role manages global quality teams, regulatory submissions, and cross-functional collaboration across multiple Pennsylvania and New Jersey sites.

Responsibilities

• Lead global quality strategy and oversight for assigned large molecule products from early development through launch
• Represent Global Quality on CMC and value chain teams, serving as primary quality contact
• Review and approve regulatory submissions and health authority filings; support audits and inspections
• Define and oversee QA resources for global quality assurance across assigned product portfolio
• Manage product quality complaints, trend analysis, and coordinate investigations with cross-functional teams

Requirements

• Experience managing quality strategy for biopharmaceutical product development and commercialization
• Knowledge of CMC, regulatory submissions (IND, BLA, NDA, MAA), and health authority interactions
• Cross-functional leadership experience with manufacturing, analytical, and value chain teams
• Strong communication and stakeholder management across global quality functions
• Experience with product quality complaints management and issue resolution
• Understanding of design for manufacturability and quality control strategies