QA Release Senior Quality Reviewer

Location: Swiftwater, PA

About the role

This role provides quality oversight of the Batch Release Protocol (BRP) process and final release to market. The position performs final review and approval of all batch release protocols for both foreign and domestic submissions within a highly collaborative and technical vaccine manufacturing operation on a park-like campus.

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. With a deep understanding of the immune system and an innovative pipeline, Sanofi invents medicines and vaccines that treat and protect millions of people worldwide.

Responsibilities

• Ensure activities within scope comply with applicable regulatory requirements
• Ensure all batch release activities comply with Good Manufacturing Practices (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 across the organization
• Participate in internal and external audits and regulatory inspections, providing support and documentation
• Investigate and resolve issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)
• Collaborate with regulatory affairs to ensure compliance with local and international regulations
• Implement continuous improvement initiatives to enhance batch release efficiency and effectiveness
• Participate in Quality Alert/Product Alert meetings and ensure investigation and actions allow disposition of lots
• Prioritize quality and compliance objectives (Decision authority)
• Approve a batch record if correctly completed and meeting quality requirements for one lot (Decision authority)
• Check whether all practices meet quality requirements; if not, ensure a deviation is opened and reported in the batch record (Decision authority)
• Review and approve documentation for batch disposition (Approval authority)
• Release all stages of batches, focusing on formulation, master/fill/inspect, and packaged stages
• Advise on initiatives to promote a quality-focused culture (Advisory role)
• Advise on how to present topics and answer specific questions (Advisory role)
• Perform any other tasks assigned by Manager

Requirements

• Bachelor's degree
• 3+ years of experience in Quality Assurance within the pharmaceutical industry
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

Skills

Technical Skills

• Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards
• Capability to investigate and resolve issues or deviations related to batch release processes efficiently
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
• Strong computer literacy (including Microsoft Excel, PowerPoint, Word)

Soft Skills

• Ability to analyze complex data and identify trends, issues, and solutions
• High level of accuracy and attention to detail in all quality assurance activities
• Proficiency in identifying problems and implementing effective corrective actions
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
• High level of autonomy

Benefits

• Be part of an inspiring mission to create life-saving vaccines
• Lead a skilled and motivated team of quality professionals
• Work in a highly collaborative, technical vaccine manufacturing operation on a beautiful park-like campus
• Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
• At least 14 weeks' gender-neutral parental leave
• Thoughtful, well-crafted rewards package recognizing contribution and amplifying impact
• Endless opportunities to grow talent and drive career through promotions or lateral moves, at home or internationally
• Shape the future of medicine and vaccine delivery with cutting-edge technology
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime