Quality Complaint Specialist

Job Title:

Quality Complaint Specialist

• Location:
  
  Swiftwater, PA

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

We’re 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 of people around the world. Together, we chase the miracles of science to improve lives.

Supporting the implementation and maintenance of the complaint (Third Party/Product Technical) management process

• Assisting in the management and oversight of the site complaint handling process to ensure timely and effective resolution of product complaints
• Communicating with customers regarding the status and resolution of their complaints
• Documenting and maintaining records of complaint management activities and communications
• Assisting in investigations into product complaints, including root cause analysis and corrective actions
• Collaborating with cross-functional teams to address and resolve complaints
• Analysing complaint data to identify trends and potential areas for product improvement
• Supporting audits and inspections by providing required information related to complaint management
• Ensuring process performance with other entities/sites involved in the management of complaints at the site level

• Decide on the coordination of specific complaint investigations, ensuring thorough root cause analysis and appropriate corrective actions (D)
• Advise cross-functional teams to address and resolve complaints (A)

• Bachelor's Degree with 3+ years of experience in Quality Assurance, Quality control, Quality operations, Third party vendor management, complaint management or other related fields.

• Degrees in Life Sciences, pharmaceutical sciences, Engineering or Business are preferred.
• Experience working in the pharmaceutical industry is a plus.

• Ability to analyze complex data sets, identify trends, and draw meaningful conclusions to improve complaint handling processes and product quality
• Excellent verbal and written communication skills to effectively interact with cross- functional teams, regulatory bodies, and customers, and to prepare detailed reports and presentations
• Strong problem-solving abilities to identify root causes of product complaints and implement effective corrective and preventive actions (CAPA)
• High level of attention to detail to ensure accuracy in complaint records, compliance with regulatory requirements, and thoroughness in investigations
• Proficiency in managing multiple projects simultaneously, prioritizing tasks, and ensuring timely completion of complaint investigations and related activities

• Fluent in Reading, Writing, Speaking English

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring…