Senior QA Program Lead: NPI, Tech Transfer & Compliance

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

Benefits offered by this job

Target bonus 8%

Job summary

LOTTE Biologics in East Syracuse, NY seeks a Sr. Specialist, QA Program Management to oversee QA activities in a CDMO environment, ensuring cGMP compliance for new product introductions, technical transfers, and lifecycle management.

The role conducts QA deliverables, reviews documentation, and provides on-the-floor manufacturing QA oversight. It supports deviations, CAPAs, change controls, and client requirements while collaborating across functions to ensure compliant decisions.

Qualifications

• Bachelor's degree in Biotechnology, Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or related discipline.
• Minimum of 2–4 years in a cGMP-regulated pharma/CDMO environment, with QA exposure.
• Experience with quality systems and compliance activities (deviations, CAPAs, change controls, investigations, validation, NPI).
• Hands-on experience with an electronic QMS (eQMS) is preferred; familiarity with Veeva Vault Quality/QualityOne is highly desirable.

Responsibilities

• Execute QA activities to enable NPI, technical transfers, and lifecycle management per cGMP and client requirements.
• Review documentation for alignment with Quality Agreements and client needs; identify gaps and action items.
• Issue Quality-related client notifications and escalations as needed.
• Draft and maintain Quality Agreements with input from stakeholders.
• Assist in inspection/audit readiness and act as QA representative during audits.
• Drive client-specific change controls and track actions; support deviation and CAPA processes.
• Provide QA oversight of site deviations and CAPAs with root-cause analysis.

Skills

cGMP knowledge

Problem solving

Multitasking

Cross-functional collaboration

Data analysis

Communication

Quality awareness

Education

Bachelor's degree in Biotechnology/Life Sciences/related

Tools

Veeva Vault Quality/QualityOne

TrackWise

MasterControl

Job description

LOTTE Biologics in East Syracuse, NY seeks a Sr. Specialist, QA Program Management to oversee QA activities in a CDMO environment, ensuring cGMP compliance for new product introductions, technical transfers, and lifecycle management.

The role conducts QA deliverables, reviews documentation, and provides on-the-floor manufacturing QA oversight. It supports deviations, CAPAs, change controls, and client requirements while collaborating across functions to ensure compliant decisions.