Qualification & Validation Specialist

Sanofi • Northborough, MA

1d • $113,250 - $163,583 • Onsite

About The Position

The Qualification & Validation Specialist provides quality oversight of qualification and validation activities within their area. The role prepares and reviews lifecycle documentation—including protocols, reports, risk assessments, and traceability matrices—and ensures activities meet regulatory requirements and company quality standards. The specialist supports the MA BioCampus validation program, helping maintain inspection readiness in alignment with regulatory requirements, current industry standards, and global Sanofi procedures.

The Quality & Validation department reviews and approves validation lifecycle documents, procedures, and technical reports related to facilities, equipment, utilities, cleaning, processes, analytical methods, requalification, sterilization, transport, and computer systems. This role partners with engineering, manufacturing, and quality control teams, supports audits and inspections, and contributes validation expertise and continuous improvement. The position is located in Framingham, Massachusetts.

Requirements

• Bachelor's degree in science, engineering, a technical field, or any field with 9 or more years of experience working in a regulated GxP environment; alternatively, a master's degree with 6 or more 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 deviations, non-conformances, and corrective actions are properly documented.
• Evaluate change controls using qualification and validation expertise.
• 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 documentation and support.
• Cooperate with engineering, manufacturing, and quality control teams to support 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

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

What This Job Offers

• Job Type: Full-time