QC Analyst

About the role

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.

Sanofi is 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.

Responsibilities

• Perform QC data review of executed tests by other analysts in a timely manner, ensuring adherence to scheduled plans.
• Inform manager of any quality or HSE event (deviations, OOx,…) promptly for investigation and impact assessment.
• Participate actively in investigations where involved, supporting root cause analysis for testing deviations.
• Coordinate quality control documentation lifecycle activities, including review, approval, and distribution.
• Ensure documentation compliance with Good Documentation Practices (GDP) and maintain QC technical documentation and SOPs.
• Monitor document revision schedules and coordinate periodic reviews.
• Liaise with subject matter experts for document content development and support metadata management in quality systems (e.g., QualiPSO).
• Coordinate stakeholder reviews and consolidate feedback.
• Execute assigned CAPAs related to remediation plans and continuous improvements.
• Maintain lab facilities and instruments in a quality and safety status for appropriate use.
• Execute analytical testing in a timely manner, adhering to scheduled plans.
• Perform tasks in accordance with cGMP and HSE requirements, following associated instructions, procedures, and records.
• Record all raw data, calculations, and information to comply with cGMP and data integrity requirements.
• Support laboratory and deviation investigations.

Typical Activities

• Review test data for accuracy, completeness, and compliance.
• Coordinate creation, review, and approval of QC SOPs and technical documents.
• Manage document change requests and assess impact on testing operations.
• Facilitate document review meetings with cross‑functional teams.
• Maintain document control records and ensure proper version management.
• Support regulatory inspections by providing documentation and technical expertise.
• Participate in CAPA investigations related to testing or documentation issues.
• Monitor documentation metrics and report on completion status.
• Train laboratory personnel on new or revised procedures.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related field.
• 3–5 years of experience in QC laboratory operations; pharmaceutical environment preferred.
• Strong understanding of GxP requirements and pharmaceutical quality systems.
• Experience with analytical testing methods and equipment.
• Proficiency in document management systems (e.g., QualiPSO, electronic document management systems).
• Knowledge of test data review processes and data integrity principles.
• Experience coordinating documentation workflows and managing stakeholder reviews.
• Excellent attention to detail and organizational skills.
• Strong written and verbal communication skills.
• Knowledge of iShift functionality and navigation is preferred.

Benefits

• Opportunities for career growth through promotions, lateral moves, and international assignments.
• Comprehensive rewards package recognizing contributions.
• Health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs.
• At least 14 weeks of gender‑neutral parental leave.