Quality Complaint Specialist

Regulatory Toolkit; Pennsylvania; On-site; USD 69,000 - 100,000; Full time

Job summary

Sanofi Inc. in Swiftwater, PA, is seeking a Quality Complaint Specialist to support the complaint management process within Manufacturing & Supply.

You will assist with site complaint handling, communicate with customers, document activities, and help investigations to identify root causes and implement CAPA. The role requires a Bachelor’s degree and 3+ years in QA/complaint management, with strong data analysis and excellent English communication.

Qualifications

• Bachelor's degree and 3+ years of experience in Quality Assurance, Quality control, Quality operations, or complaint management.
• Excellent verbal and written communication skills to interact with cross-functional teams, regulatory bodies, and customers.
• Experience with root cause analysis and corrective actions (CAPA) and familiarity with regulatory requirements.

Responsibilities

• Support the implementation and maintenance of the complaint management process.
• Assist in management and oversight of site complaint handling to ensure timely resolution.
• Communicate with customers regarding status and resolution of complaints.
• Document and maintain records of complaint management activities and communications.
• Assist investigations into product complaints including root cause analysis and CAPA.
• Collaborate with cross-functional teams to address and resolve complaints.
• Analyze complaint data to identify trends and potential product improvements.
• Support audits and inspections by providing required information related to complaint management.
• Ensure process performance with other entities/sites involved in site-level complaint management.

Skills

Data analysis

Communication

CAPA

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree

Job description

Job Title

Quality Complaint Specialist

• Location: Swiftwater, PA

About the Job

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.

About Sanofi

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.

Main Responsibilities

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

Key roles (D,A,I) - Key involvement in Decision Making process

• 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)

About You

Basic Qualifications

• 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.

Preferred Qualifications

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

Expected Technical skills

• 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

Language

• Fluent in Reading, Writing, Speaking English

Why choose us?

• 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 andwellness programs and at least 14 weeks’ gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

$69.000,00 - $99.666,66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.