Qualification & Validation Specialist

Sanofi • Framingham, MA

7d • Onsite

About The Position

The Qualification & Validation Specialist works within Sanofi’s Quality & Validation (Q&V) department, the Quality Unit responsible for reviewing and approving validation lifecycle documents, procedures, and technical reports. The scope includes facilities, equipment, utilities, cleaning, processes, analytical methods, requalification, sterilization, transport, and computer systems. Q&V provides leadership, direction, and oversight for the MA BioCampus validation program and supports inspection readiness in accordance with regulatory requirements, current industry standards, and Sanofi procedures.

The specialist provides quality oversight of qualification and validation activities, prepares and reviews relevant documentation, and helps ensure compliance with regulatory and company quality requirements. The role collaborates with engineering, manufacturing, quality control, and other teams; supports audits and inspections; and contributes validation expertise and process improvements.

The position is located in Framingham, Massachusetts. Sanofi describes its work as R&D-driven and AI-powered, focused on medicines and vaccines, and highlights opportunities for career growth, a rewards package, healthcare and wellness benefits, and at least 14 weeks of gender-neutral parental leave.

Requirements

• Bachelor’s degree in science, engineering, a technical field, or any field with at least 9 years of experience working in a regulated GxP environment; alternatively, a master’s degree with at least 6 years of experience working in a regulated GxP environment.

Nice To Haves

• Proficiency in preparing and reviewing qualification and validation documentation, including protocols, reports, and standard operating procedures (SOPs).
• Strong understanding of regulatory requirements and guidelines, including FDA and EMA requirements, related to validation and qualification.
• Ability to manage multiple validation projects simultaneously and complete them on time and within budget.
• Expertise in conducting risk assessments, analyzing validation data, and resolving deviations and non-conformances.
• Excellent communication skills to collaborate with cross-functional teams and train staff on validation procedures and best practices.

Responsibilities

• Provide quality oversight of qualification and validation tasks in the assigned area.
• Prepare and review qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices, according to predefined timelines.
• Ensure proper documentation of deviations, non-conformances, and corrective actions.
• Ensure appropriate validation-expertise evaluation of change controls.
• Ensure qualification and validation activities comply with regulatory requirements, including FDA and EMA requirements, and company quality standards.
• Participate in internal and external audits and inspections, providing necessary documentation and support.
• Cooperate with cross-functional teams, including engineering, manufacturing, and quality control, to support smooth execution of validation activities.
• Provide qualification and validation expertise when requested.
• Identify opportunities to improve qualification and validation processes and contribute to continuous improvement initiatives.

Benefits

• Thoughtful rewards package recognizing employee contributions.
• Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employees may be eligible to participate in company employee benefit programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior