Qualification & Validation Specialist

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

Qualification & Validation Specialist

• Location: Framingham, MA

About The Job

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 BioCampus validation program and is responsible for ensuring inspection readiness in alignment with regulatory compliance requirements, current industry standards, and global Sanofi procedures.

About Sanofi

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.

Main 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.

About You

Basic Qualifications

• 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.

Preferred Qualifications

• 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

Why choose us?

• 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 high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Afffirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.