Senior QA Program Manager - NPI & Change Control

LOTTE BIOLOGICS USA, LLC; City of Syracuse (NY); On-site; USD 60,000 - 88,000; Full time

Job summary

LOTTE BIOLOGICS USA, LLC is seeking a Senior Specialist, QA Program Management to oversee client QA activities within a CDMO setting. You will ensure alignment with Quality Agreements, client requirements, and site procedures while guiding deviations, CAPAs, and change controls.

The role also involves supporting APQRs, NPI documentation, and manufacturing QA oversight. The successful candidate will have a 2–4 year background in a cGMP-regulated environment, hands-on eQMS experience, and strong

Qualifications

• Bachelor's degree in Biotechnology, Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or related field.
• 2–4 years of experience in a cGMP-regulated pharma/biotech/CDMO.
• Experience with quality systems, deviations, CAPAs, change controls, investigations, document management or validation.

Responsibilities

• Execute QA activities for NPI, tech transfers, and lifecycle management in a cGMP environment.
• Review documents for Quality Agreements, site procedures, and client requirements.
• Issue and manage quality-related client notifications and escalations.
• Draft, review, and maintain Quality Agreements with clients.
• Support audits as QA representative and coordinate responses with senior QA staff.
• Lead client-specific change controls including impact assessments and action tracking.
• Review deviations, CAPAs, and validation documentation for compliance.
• Assist in preparation of APQRs and review NPI documentation (MBRs, SOPs, protocols).
• Provide manufacturing QA oversight to ensure GMP compliance and operational standards.

Skills

GMP knowledge

Quality Assurance

Cross-functional collaboration

Regulatory understanding

Education

Bachelor's degree in Biotechnology or related

Tools

eQMS

Veeva Vault

Job description

LOTTE BIOLOGICS USA, LLC is seeking a Senior Specialist, QA Program Management to oversee client QA activities within a CDMO setting. You will ensure alignment with Quality Agreements, client requirements, and site procedures while guiding deviations, CAPAs, and change controls.

The role also involves supporting APQRs, NPI documentation, and manufacturing QA oversight. The successful candidate will have a 2–4 year background in a cGMP-regulated environment, hands-on eQMS experience, and strong