Qualification & Validation Specialist

(5102) Genz. Therap Product LP; Framingham (MA); On-site; USD 113,000 - 164,000; Full time

Job summary

Sanofi Group in Framingham, MA is seeking a Qualification & Validation Specialist to lead QA oversight of validation activities across facilities, equipment, utilities, processes, and software systems. You will prepare and review qualification documents and ensure traceability and timely closure of deviations, CAPAs, and change controls.

Join a dynamic team within a global biopharma company focused on regulatory compliance (FDA/EMA), risk assessments, and continuous improvement to support

Qualifications

• Bachelor's degree in science, engineering, or related field with 9+ years in GxP.
• Master's degree with 6+ years in GxP.
• Experience preparing qualification documentation (protocols, reports, SOPs).
• Regulatory knowledge (FDA, EMA) related to validation.
• Ability to manage multiple validation projects.
• Experience with risk assessments and handling deviations.

Responsibilities

• Quality oversight of qualification and validation tasks.
• Prepare and review qualification/validation docs: protocols, reports, risk assessments, traceability matrices.
• Document deviations, non-conformances, and corrective actions.
• Evaluate changes controls validation.
• Ensure regulatory compliance per FDA/EMA and company standards.
• Assist audits and inspections with documentation.
• Collaborate with engineering, manufacturing, QC to execute validation activities.
• Provide expertise and support on validation; drive process improvements.

Skills

Validation documentation

Regulatory requirements (FDA/EMA)

Change controls analysis

Audits & inspections support

Cross-functional collaboration

Education

Bachelor's degree + 9+ years in GxP

Master's degree + 6+ years in GxP

Job description

Job Title: 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.

Equal Opportunity Statement

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative 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.

Equal Opportunity Statement (Repeat)

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

Salary Range

The salary range for this position is: $113,250.00 - $163,583.33 All compensation will be determined commensurate with demonstrated experience.

Benefits

Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Additional Information

We are an R&D driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.