Senior QA Program Lead - Client-Facing & NPI Expert

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 during new product introduction and technical transfer activities.

You will interact directly with client Quality representatives, negotiate Quality Agreements, and oversee site deviations and CAPA to ensure compliance and successful operations. The role requires leading QA teams, ensuring training, and maintaining compliant documentation and processes across cGMP manufacturing environments.

Qualifications

• Bachelor's degree in Biotechnology, Biology, Microbiology, Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field.
• 10+ years of progressive experience in Quality Assurance, Quality Systems, or related functions within cGMP environments.
• Experience with client-facing quality activities, technical transfer, NPI, change control, deviations, CAPA, and Quality Agreements.

Responsibilities

• Leads QA program teams and provides management oversight.
• Interfaces with clients during NPI and technical transfer activities as Quality SME.
• Oversees deviation investigations and CAPA to prevent recurrence.
• Ensures QA personnel have necessary training and qualifications.
• Reviews Master Batch Records and SOPs for accuracy and compliance.
• Approves process validation documentation and maintains inspection readiness.

Skills

Client communication

Quality systems

Regulatory knowledge

Leadership

Education

Bachelor's degree in biotech/chemistry/engineering

Job description

LOTTE BIOLOGICS USA, LLC in New York seeks a Sr. Manager QA Program Lead to provide QA expertise during new product introduction and technical transfer activities.

You will interact directly with client Quality representatives, negotiate Quality Agreements, and oversee site deviations and CAPA to ensure compliance and successful operations. The role requires leading QA teams, ensuring training, and maintaining compliant documentation and processes across cGMP manufacturing environments.