Senior QA Release Lead – Vaccine Quality

Regulatory Jobs; Pennsylvania; On-site; USD 78,000 - 113,000; Full time

Benefits offered by this job

Life-saving vaccines mission

Team leadership in QA

On-site park-like campus

Job summary

Sanofi US is seeking a QA Release Senior Quality Reviewer at the Swiftwater, PA site to ensure product quality through batch release processes and final release to market.

You will provide quality oversight of the Batch Release Protocol (BRP), perform final review of batch release protocols for domestic and international submissions, and coordinate with supply chain and regulatory affairs to schedule releases.

Qualifications

• Bachelor's degree in a relevant field.
• 3+ years of QA experience in the pharmaceutical industry.
• Strong knowledge of GMP and QA principles.

Responsibilities

• Ensure activities are conducted in compliance with applicable regulatory requirements.
• Ensure batch release activities comply with GMP.
• Review and perform final approval of batch release protocols.
• Perform final approval of batch release protocol product configurations.
• Coordinate with supply chain and regulatory affairs to schedule batch release protocols and priorities.
• Perform ship approval for batches destined for international countries.
• Foster a culture of quality and continuous improvement.
• Participate in internal and external audits and regulatory inspections providing support and documentation.
• Investigate and resolve issues or deviations related to batch release.
• Collaborate with regulatory affairs to ensure compliance with local and international regulations.
• Implement continuous improvement initiatives to enhance batch release efficiency and effectiveness.

Skills

Batch record review

Deviations investigation

Project management

MS Office

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Sanofi US is seeking a QA Release Senior Quality Reviewer at the Swiftwater, PA site to ensure product quality through batch release processes and final release to market.

You will provide quality oversight of the Batch Release Protocol (BRP), perform final review of batch release protocols for domestic and international submissions, and coordinate with supply chain and regulatory affairs to schedule releases.