GxP Qualification & Validation Lead

Sanofi; Framingham (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Sanofi in Framingham, MA is seeking a Qualification & Validation Specialist to lead oversight of qualification and validation tasks across facilities, equipment, processes, and analytical methods, ensuring regulatory compliance.

You will prepare and review protocols and reports, manage deviations and change controls, and collaborate with engineering, manufacturing, and quality control to drive on-time validation activities and inspections readiness.

Qualifications

• Bachelor's degree in science, engineering, technical field or related area with 9+ years in a regulated GxP environment.
• OR Master's degree with 6+ years in a regulated GxP environment.
• Proficiency in preparing and reviewing qualification documentation (protocols, reports, SOPs).
• Strong understanding of FDA/EMA regulatory requirements related to validation.
• Experience managing multiple validation projects and change controls.
• Excellent communication skills for cross-functional collaboration.

Responsibilities

• Quality oversight of qualification and validation tasks in his/her area.
• Preparing and reviewing qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices according to pre-defined timelines.
• Ensuring proper documentation of deviations, non-conformances, and corrective actions
• Ensuring proper evaluation (validation expertise) of change controls
• Ensuring all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards
• Participating in internal and external audits and inspections, providing necessary documentation and support
• Cooperating with cross-functional teams, including engineering, manufacturing, and quality control, to ensure smooth execution of validation activities
• Providing qualification and validation expertise when requested
• Identifying opportunities for improving qualification and validation processes and contributing to continuous improvement initiatives.

Skills

Documentation

Regulatory knowledge

Project management

Communication

GxP experience

Education

Bachelor's degree in science/engineering/technical field

Master's degree (6+ years in GxP environment)

Job description

Sanofi in Framingham, MA is seeking a Qualification & Validation Specialist to lead oversight of qualification and validation tasks across facilities, equipment, processes, and analytical methods, ensuring regulatory compliance.

You will prepare and review protocols and reports, manage deviations and change controls, and collaborate with engineering, manufacturing, and quality control to drive on-time validation activities and inspections readiness.