New · posted Nov 5
Sanofi · Pharmaceuticals
Quality Assurance Specialist
- Framingham, MA
- On-site
- Full-time
- Associate & Specialist
The role
Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi's Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
Location: Framingham, MA
What you need
Two ways to qualify
Bachelor’s
+ 6 years of experience
Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and / or cGMP environment.
- or
Bachelor’s
+ 4 years of experience
Bachelor’s degree in a scientific field with 4 years of experience in a Quality and / or cGMP environment.
Basic Qualifications
Bachelor’s Degree in a scientific field and 4 years of related experience, associate’s degree and 6 years of related experience or High School Diploma and 8 years of related experience in a Quality and /or other CGMP related field.
Basic to Intermediate computer proficiency, strong verbal and written communication skills.
Experience with quality systems and cGMP data review
Preferred Qualificationsnice to have
Experience in bio-pharmaceutical industry.
Strong technical writing skills
Effective time management, attention to detail, organizational skills, teamwork and collaborations.
Demonstrated competence in problem solving methodology.
Experience participating and/or leading cross-functional project team collaborations.
Special Working Conditions:
Ability to gown and gain entry to manufacturing areas
Ability to work a 10-hour shift with rotating weekend coverage, including some holidays
Ability to lift 10 lbs
What you'll do
The Quality Assurance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Quality Assurance Specialist is also responsible for mentoring and supporting the junior staff.
Core Responsibilities include:
Provide Gemba Support
Perform batch record review
Perform review of column packing and qualification records
Function as SME on input related to quality decisions
Approve Non-conforming material discards
Perform log book review
Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
Issue action notices and conduct affiliated provisional release
Conduct log book audits against compliance requirements
Review Cleaning Verification (CV) related documentation against specification
Perform media / buffer and intermediate release
Prepare Bioreactor summary
Support internal audit preparation activities as well as cross-functional internal audit activities and conduct walkthrough inspections
Execute containment activities
Provide off-hour support for batch record and log book issuance
Partner with manufacturing and support operations to ensure a culture of continuous compliance
May provide training to new employees
Revise procedures / SOPs
Initiate and Investigate and QA review deviations
Review NRSR (Non-Routine Sample Requests)
Other activities as assigned
Leadership Qualifications:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
Pay and benefits
$69,000 – $99,667 a year
Employer providedNorth America Applicants Only
The salary range for this position is:
$69,000.00 - $99,666.66
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, 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
* Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
Sanofi US Services 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.
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 · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US16 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $69,000 | — | $99,667 |
| All US (middle half) | $81,375 | $85,250 | $96,125 |
This role: Sanofi's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 87 open Quality Operations & Batch Release 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 45 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance9
- Documentation and SOPs8
- Collaboration and leadership8
- Lab testing and methods2
- Investigations and CAPA2
- Data and digital systems2
- Validation and qualification1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
Company hiring pulse
Sanofi on Regulatory Jobs
- 26
- Open roles
- 20
- Distinct roles
- 6
- Locations
By discipline
- Quality15 58%
- Regulatory6 23%
- Clinical5 19%
By level
- Senior & Principal9 35%
- Director5 19%
- Associate & Specialist5 19%
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Quality Assurance Specialist at Sanofi
Applications close November 20. $69K–$100K a year, employer provided.