QA Program Lead - Client-Facing NPI & Quality

LOTTE BIOLOGICS USA, LLC; City of Syracuse (NY); On-site; USD 91,000 - 142,000; Full time

Job summary

LOTTE BIOLOGICS USA, LLC in New York seeks a Sr. Manager QA Program Lead to provide QA expertise for new product introductions and technical transfers, and to act as the primary Quality contact for clients.

You will drive deviation management, CAPA, and change controls to ensure compliance with Quality Agreements. The role requires strong GMP knowledge, leadership, and ability to coordinate across QA, manufacturing, and client teams, with travel as needed to support inspections and client

Qualifications

• Bachelor's degree in a scientific field required.
• 10+ years of QA/Quality systems experience in cGMP environments.
• Experience supporting client-facing quality activities and NPI/tech transfer.
• Leadership or cross-functional team leadership experience preferred.

Responsibilities

• Leads QA program teams and interfaces with clients as QA SME.
• Oversees deviation investigations, CAPA, and change controls.
• Reviews and approves MBRs, SOPs, and process validation docs.
• Ensures training and qualifications of QA personnel.
• Supports site readiness for inspections and client visits.

Skills

Quality leadership

Client-facing comms

GMP knowledge

Project management

Regulatory compliance

Education

Bachelor's degree in Biotechnology/related

Tools

GxP systems

Job description

LOTTE BIOLOGICS USA, LLC in New York seeks a Sr. Manager QA Program Lead to provide QA expertise for new product introductions and technical transfers, and to act as the primary Quality contact for clients.

You will drive deviation management, CAPA, and change controls to ensure compliance with Quality Agreements. The role requires strong GMP knowledge, leadership, and ability to coordinate across QA, manufacturing, and client teams, with travel as needed to support inspections and client