Qualification & Validation Specialist

Location:

Framingham, MA

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Quality & Validation (Q&V) department is the Quality Unit that reviews and approves validation lifecycle documents, procedures, and technical reports related to (1) facilities, equipment, utilities, (2) cleaning, (3) processes, (4) analytical methods, (5) requalification, (6) sterilization, (7) transport, and (8) computer systems. Q&V provides leadership, direction, and oversight for the MA Bio Campus validation program and is responsible for ensuring inspection readiness in alignment with regulatory compliance requirements, current industry standards, and global Sanofi procedures.

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.

• 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.

• Bachelor's degree in science, engineering, technical field or any field with 9+ years of experience working in a regulated GxP environment OR Master's degree with 6+ years of experience working in a regulated GxP environment.

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

• 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…