Senior QA Program Lead — NPI & Client Quality Partner
Lotte Biologics
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Benefits offered by this job
Job summary
LOTTE BIOLOGICS in East Syracuse, NY, is seeking a Sr. Manager QA Program Lead to provide QA expertise during NPI, tech transfer, and ongoing client support. You will negotiate Quality Agreements, oversee deviations, CAPAs, changes, and ensure compliance with regulatory requirements and client expectations.
You will lead QA teams, interface with client Quality reps, and drive quality oversight across start-up activities and manufacturing operations to ensure inspection readiness.
Qualifications
- Bachelor's degree in a related scientific discipline required.
- Minimum 10 years in QA, quality systems, or related functions in cGMP pharma/biotech.
- Experience supporting client-facing quality activities, technical transfer and NPI.
- Leadership experience in cross-functional teams and client communications.
Responsibilities
- Lead QA Program teams and act as QA SME for client discussions.
- Negotiate Quality Agreements and oversee deviations and CAPA.
- Approve master batch records, process documentation, and validation docs.
- Provide site quality guidance during NPI, transfers, and ongoing operations.
- Ensure compliance with regulatory requirements and client expectations.
- Travel as needed (up to 10–25%).
Skills
Education
Job description
LOTTE BIOLOGICS in East Syracuse, NY, is seeking a Sr. Manager QA Program Lead to provide QA expertise during NPI, tech transfer, and ongoing client support. You will negotiate Quality Agreements, oversee deviations, CAPAs, changes, and ensure compliance with regulatory requirements and client expectations.
You will lead QA teams, interface with client Quality reps, and drive quality oversight across start-up activities and manufacturing operations to ensure inspection readiness.
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