Senior Quality Lead, Vaccine CMC DP (Remote)

Sabin Foundation Europe; Only (TN); On-site; USD 135,000 - 165,000; Full time

Benefits offered by this job

medical, dental, and vision coverage

flexible spending accounts

flexible vacation and sick leave

employer-paid life and disability

401(k) plan

Job summary

Sabin Foundation Europe is seeking a Senior Manager, Quality CMC DP to provide oversight in vaccine manufacturing, from development to commercialization. This remote position focuses on ensuring cGMP compliance and managing quality activities to support vaccine production.

The ideal candidate will have extensive experience in biologics and vaccine manufacturing, and be skilled in technology transfers and regulatory inspections.

Qualifications

• 9+ years of Quality experience supporting biologics, vaccines, or pharmaceutical DP manufacturing.
• Proven experience supporting technology transfer, process validation, PPQ execution, manufacturing readiness, and commercial launch preparation.
• Strong knowledge of 21 CFR Parts 210 and 211, Annex 1, ICH Q10, and global cGMP requirements applicable to sterile drug product manufacturing.

Responsibilities

• Provide cGMP oversight and risk-based quality decision-making across clinical and late-stage DP activities.
• Provide Quality oversight for clinical manufacturing, engineering runs, and technology transfer.
• Review batch records, deviations, and analytical data to support product disposition decisions.

Skills

Quality oversight

cGMP compliance

Regulatory inspections

Technology transfer

Process validation

Biologics experience

Education

Bachelor's or advanced degree in scientific discipline

Job description

Sabin Foundation Europe is seeking a Senior Manager, Quality CMC DP to provide oversight in vaccine manufacturing, from development to commercialization. This remote position focuses on ensuring cGMP compliance and managing quality activities to support vaccine production.

The ideal candidate will have extensive experience in biologics and vaccine manufacturing, and be skilled in technology transfers and regulatory inspections.