Senior QA Release Reviewer - GMP & Batch Lead

Sanofi; Swiftwater (Monroe County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Park-like campus

Collaborative team environment

Career growth opportunities

Job summary

Sanofi in Swiftwater, PA is seeking a QA Release Senior Quality Reviewer to oversee the BRP process and final release to market. You will review and approve batch release protocols for foreign and domestic submissions, ensuring GMP compliance and robust quality controls.

Join a global team within Manufacturing & Supply to advance life-saving vaccines, operate in a highly collaborative, technically advanced setting, and contribute to continuous improvement across the batch release lifecycle.

Qualifications

• Bachelor's degree in a related field.
• 3+ years of experience in Quality Assurance within pharmaceutical manufacturing.
• Strong knowledge of GMP and quality assurance principles.

Responsibilities

• Ensure activities are conducted in compliance with regulatory requirements.
• Review and provide final approval of batch release protocols.
• Perform final approval of batch release protocol configurations.
• Coordinate with supply chain and regulatory affairs to schedule batch release activities.
• Perform ship approvals for batches destined for international markets.
• Support audits and regulatory inspections with documentation.

Skills

Quality Assurance

GMP

Batch records review

Data analysis

Project management

Quality documentation

Education

Bachelor's degree

Tools

Microsoft Excel

PowerPoint

Microsoft Word

Job description

Sanofi in Swiftwater, PA is seeking a QA Release Senior Quality Reviewer to oversee the BRP process and final release to market. You will review and approve batch release protocols for foreign and domestic submissions, ensuring GMP compliance and robust quality controls.

Join a global team within Manufacturing & Supply to advance life-saving vaccines, operate in a highly collaborative, technically advanced setting, and contribute to continuous improvement across the batch release lifecycle.