Quality Manager

Quality Manager role within the Recombinant Proteins Business Unit at Thermo Fisher Scientific's Cranbury, NJ facility. Leads quality oversight for the PeproGMP product portfolio, manages the Quality Control laboratory team, and ensures compliance with GMP, ISO 9001, and regulatory requirements while driving continuous improvement.

Responsibilities

• Provide quality leadership and oversight for the PeproGMP product portfolio and compliance execution
• Lead, develop, and manage the Quality Control team at the Cranbury site
• Oversee quality records including nonconformances, deviations, CAPAs, and customer complaints
• Drive quality and QC performance analysis to identify risks and improvement opportunities
• Partner with operations and cross-functional teams to resolve product and process quality issues

Requirements

• Quality management experience in regulated manufacturing or GMP environments
• Leadership experience managing quality or laboratory teams
• Knowledge of ISO 9001 and Quality Management Systems
• Understanding of GMP regulations, quality investigations, and deviation management
• Strong analytical and risk-based decision-making capabilities
• Cross-functional collaboration and stakeholder engagement skills