QA Release Senior Quality Reviewer

Sanofi • Swiftwater, PA

5d

About The Position

This role provides quality oversight of the Batch Release Protocol (BRP) process and final release to market. The reviewer performs final review and approval of batch release protocols for domestic and foreign submissions, coordinates release priorities, and supports compliant batch disposition and shipping. The position is part of Sanofi’s vaccine manufacturing operation in Swiftwater, Pennsylvania, working with quality, supply chain, and regulatory affairs teams.

Requirements

• Bachelor’s degree.
• At least 3 years of Quality Assurance experience within the pharmaceutical industry.
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles.
• Ability to meticulously review batch records and documentation for accuracy and regulatory compliance.
• Ability to investigate and efficiently resolve batch-release issues or deviations.
• Ability to manage multiple projects and complete them on time while meeting quality standards.
• Computer literacy, including Microsoft Excel, PowerPoint, and Word.
• Ability to analyze complex data and identify trends, issues, and solutions.
• High accuracy and attention to detail.
• Ability to identify problems and implement effective corrective actions.
• Strong verbal and written communication skills for interacting with team members and regulatory bodies.
• High level of autonomy.

Responsibilities

• Ensure activities within the role’s scope comply with applicable regulatory requirements and Good Manufacturing Practices (GMP).
• Review and provide final approval of batch release protocols and product configurations.
• Coordinate batch release protocol schedules and priorities with supply chain and regulatory affairs.
• Perform ship approval for batches destined for international countries.
• Promote a culture of quality and continuous improvement across the organization.
• Participate in internal and external audits and regulatory inspections, providing support and documentation.
• Investigate and resolve batch-release issues or deviations, including product-specific temperature excursion evaluations when unusual distribution events occur.
• Collaborate with regulatory affairs to ensure compliance with local and international regulations.
• Implement initiatives to improve batch-release efficiency and effectiveness.
• Participate in Quality Alert and Product Alert meetings, ensuring investigations and actions support lot disposition decisions.
• Prioritize quality and compliance objectives; approve batch records that are complete and meet quality requirements; and ensure deviations are opened and reported when practices do not meet requirements.
• Review and approve documentation for batch disposition and release batch stages, with a focus on formulation, master/fill/inspect, and packaged stages.
• Advise on initiatives that promote a quality-focused culture and on presenting topics and answering specific questions.
• Perform other tasks assigned by the manager.

Benefits

• At least 14 weeks of gender-neutral parental leave.
• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• Employee benefit programs may be available.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level