New · posted Oct 30
Sanofi · Pharmaceuticals
Qualification & Validation Specialist
- Framingham, MA
- On-site
- Full-time
- Senior & Principal
The role
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.
What you need
Two ways to qualify
Bachelor’s
+ 9+ years of experience
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
+ 6+ years of experience
OR Master's degree with 6+ years of experience working in a regulated GxP environment.
Basic Qualifications
Preferred Qualificationsnice to have
- 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
What you'll do
- 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.
Pay and benefits
$113,250 – $163,583 a year
Employer providedNorth America Applicants Only
The salary range for this position is:
$113,250.00 - $163,583.33
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.
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.
14weeks
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.
Where you'll work
Framingham, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Framingham, MAWorking conditions
Job Title: Qualification & Validation Specialist
- Location: Framingham, MA
From the posting
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.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Equal opportunity, accessibility and legal noticesSanofi's statements, word for word
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.
Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here
Job intelligence
The context around this role
Live data · October 30, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts10 roles publishing pay
Senior & Principal roles in the US58 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $113,250 | — | $163,583 |
| Massachusetts (middle half) | $102,500 | $115,750 | $127,500 |
| All US (middle half) | $106,625 | $121,000 | $132,750 |
This role: Sanofi's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 30, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 131 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Sanofi's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 18 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification13
- Documentation and SOPs6
- GMP and compliance4
- Quality systems and risk4
- Collaboration and leadership4
- Investigations and CAPA2
- Lab testing and methods1
- Data and digital systems1
Company hiring pulse
Sanofi on Regulatory Jobs
- 25
- Open roles
- 21
- Distinct roles
- 6
- Locations
By discipline
- Quality17 68%
- Regulatory6 24%
- Compliance & Safety2 8%
By level
- Senior & Principal12 48%
- Manager5 20%
- Associate & Specialist4 16%
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Qualification & Validation Specialist at Sanofi
Applications close December 1. $113K–$164K a year, employer provided.