QA Release Senior Quality Reviewer
About the Role
This role provides quality oversight of the Batch Release Protocol (BRP) process and final release to market. It involves performing final review and approval of all batch release protocols for both foreign and domestic submissions. Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
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 and technical vaccine manufacturing operation on a beautiful park-like campus
- Opportunities for career growth and development in an innovative global healthcare company
- Thoughtful rewards package, including health and wellbeing benefits, and gender-neutral parental leave
Responsibilities
- Ensure activities comply with applicable regulatory requirements and Good Manufacturing Practices (GMP)
- Review and perform final approval of batch release protocols and 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
- Investigate and resolve issues or deviations related to batch release, including temperature excursion evaluation
- Collaborate with regulatory affairs to ensure compliance with local and international regulations
- Implement continuous improvement initiatives to enhance batch release efficiency
- Participate in Quality Alert/Product Alert meetings and ensure appropriate investigation and actions
Key Involvement in Decision Making
- Prioritize quality and compliance objectives
- Approve batch records if correctly completed and meeting quality requirements
- Ensure all practices adhere to quality requirements and deviations are reported
- Review and approve documentation for batch disposition
- Advise on initiatives to promote a quality-focused culture
- Provide guidance on presenting topics and answering specific questions
Qualifications
- 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
- Meticulous review of batch records and documentation for accuracy and compliance
- Ability to investigate and resolve batch release issues efficiently
- Project management skills, ensuring timely completion and adherence to quality standards
- Strong computer literacy (Microsoft Excel, PowerPoint, Word)
- Analytical skills to identify trends, issues, and solutions
- High level of accuracy and attention to detail
- Problem-solving and corrective action implementation
- Strong verbal and written communication skills
- High level of autonomy
About Sanofi
We are an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions worldwide. Together, we chase the miracles of science to improve lives.
Location: Swiftwater, PA