Senior QA Release Lead - GMP & Batch Compliance

Sanofi; Pocono Township (PA); On-site; USD 78,000 - 113,000; Full time

Job summary

Sanofi in Swiftwater, PA, is seeking a QA Release Senior Quality Reviewer to oversee BRP processes and provide final release approvals for batch release protocols. You will ensure GMP compliance, regulatory adherence, and coordination with regulatory affairs and supply chain for international shipments.

The role emphasizes quality, continuous improvement, and collaboration in a global vaccine manufacturing environment. Strong QA and GMP knowledge are essential.

Qualifications

• Bachelor’s degree required.
• 3+ years of experience in Quality Assurance within the pharmaceutical industry.
• Strong knowledge of GMP and QA principles.

Responsibilities

• Ensure activities comply with applicable regulatory requirements.
• Ensure batch release activities comply with GMP.
• Review and approve batch release protocols.
• Coordinate with supply chain and regulatory affairs to schedule batch release protocols.
• Perform ship approval for batches destined for international markets.
• Support audits and regulatory inspections with documentation.
• Investigate and resolve batch release deviations.

Skills

Batch release review

Quality Assurance

GMP knowledge

Documentation review

Regulatory compliance

Data analysis

Education

Bachelor's degree

Tools

Microsoft Excel

PowerPoint

Word

Job description

Sanofi in Swiftwater, PA, is seeking a QA Release Senior Quality Reviewer to oversee BRP processes and provide final release approvals for batch release protocols. You will ensure GMP compliance, regulatory adherence, and coordination with regulatory affairs and supply chain for international shipments.

The role emphasizes quality, continuous improvement, and collaboration in a global vaccine manufacturing environment. Strong QA and GMP knowledge are essential.