Skip to main content
Two women in white lab coats look at a computer screen together

Quality Engineer Principal

Framingham, Massachusetts
Northborough, Massachusetts
Permanent Posted on   Dec. 13, 2024 Closing on   Feb. 28, 2025
Apply now

Job Title: Quality Engineer Principal

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 Assurance Validation (QAV) department reviews and approves validation lifecycle documents, procedures, and technical reports related to (1) facilities, equipment, utilities, (2) cleaning, (3) processes, (4) analytical methods and equipment, (5) requalification, (6) sterilization, and (7) computer systems.QAV provides leadership, direction, and oversight for the MA BioCampus site validation program and is responsible for ensuring inspection readiness in alignment with regulatory compliance requirements, current industry standards, and Sanofi directives, standards and guidance.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

  • Demonstrates strong leadership qualities and embodies Sanofi's core leadership principals

  • Performs timely and complete QA review and approval of validation lifecycle documents and determines interrelated impacts to processes and systems. Ensures completeness, timeliness and accuracy of documentation such as engineering studies, validation protocols/nonconformances/reports, technical reports, engineering drawings, and MBRs/SOPs.

  • Participates in Community of Practice discussions to share best practices and raise opportunities for simplification and harmonization

  • Partners with project teams to develop the implementation strategy and change control approach for complex projects with validation impact

  • Performs validation assessments for change control requests that comply with Sanofi and Biologics Quality standards, procedures and guidance

  • Leads or participates in gap assessments against Sanofi and Biologics Quality directives/standards and authors gap remediation plans

  • Authors or reviews validation section of annual periodic product reviews

  • Proactively identifies compliance risk and presents to cross-functional site risk review team or quality council, as appropriate

  • Applies Sanofi Manufacturing System (SMS) tools to daily ways of working in order to support a culture of continuous improvement

  • Supports external regulatory inspections through consultation with other Subject Matter Experts and direct interaction with investigators for requests within area of expertise. Leads or supports execution of CAPA for external regulatory commitments.

  • Participates in formal risk assessments

  • Demonstrates 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 of 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.

About You

Basic Qualifications:

  • Bachelor's degree in Science or Engineering and a minimum of 9 years’ experience working in a regulated, cGXP environment or Master's degree and a minimum of 6 years' experience working in a regulated, cGXP environment

  • Operations experience in one or more of the following areas with demonstrated knowledge of the validation lifecycle: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Computer Systems/Automation

  • Demonstrated knowledge of cGXP regulations and guidance

  • Excellent technical writing skills

  • Direct experience with change control and CAPA quality systems

Preferred Qualifications:

  • Experience with LEAN Manufacturing (problem solving/use of LEAN tools) or comparable continuous improvement systems.

  • Experience with root cause analysis tools and gap identification.

Special working conditions:

  • Ability to gown and gain entry to manufacturing areas

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.

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.

#GD-SG   
#LI-GZ 
#LI-Onsite
#vhd

Pursue progress. Discover extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com

Apply Now
  • You have not viewed any jobs yet.

  • You have not saved any jobs yet.

Woman in lab looking at vial through magnifying goggles

Sanofi careers in the US

Join our US team and get expert mentorship and training platforms, while helping to shape our culture. Bring your passion and energy and use your skills to help create vaccines and medicines that halve the time from discovery to therapy.

Illustration of map pins on globe

Find out more about this location

Experience possibility

  • Your Saved Jobs

    Learn more
  • Cambridge Crossing

    We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.

    Learn more
  • Innovation in Action

    Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.

    Learn more
  • Sustainable and Green

    Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.

    Learn more
  • Sanofi’s AI Centre of Excellence in Toronto

    The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.

    Learn more
  • Ama

    Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.

    Learn more
  • Sanofi Canada's Philanthropic Efforts

    By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.

    Learn more
  • Emmanuel

    Emmanuel, Head of the Sanofi Digital Accelerator, shares how his team builds digital solutions that enable patients to receive new treatments to help improve their lives.

    Learn more
  • Dimitrije

    Dimitrije shares insights into the work carried out by the AI Centre of Excellence in Toronto.

    Learn more
  • Ziv

    Read Ziv's first-hand account describing the reasons he chose to join Sanofi – and many of the reasons why he now chooses to stay.

    Learn more
  • When you grow, we all grow

    We strive to support your whole self with thoughtfully crafted rewards that benefit you physically, financially, mentally and socially. Whatever your role, you'll thrive in our inclusive teams.

    Learn more
  • Build a career with purpose

    Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.

    Learn more
  • Bolder, better futures

    Change your life. And the lives of millions around the globe. How? By starting a career where you're supported to grow, while having a tangible impact and learning from the best.

    Learn more
  • Our locations

    We're in 60+ countries, all pulling together to define the future of healthcare. Wherever you work, you'll develop your career alongside experts, using technology to chase bigger breakthroughs.

    Learn more
  • Sanofi Stories

    At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.

    Learn more
  • Sanofi at Cambridge Crossing

    Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become part of a team dedicated to chasing the miracles of science that improve people’s lives.

    Learn more
  • Why Sanofi

    Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.

    Learn more
  • Our people & culture

    We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.

    Learn more
  • Sanofi's Postdoctoral Program

    Designed for high-caliber Ph.D. graduates, Sanofi's Postdoctoral Program helps you advance your scientific career in a state-of-the-art environment.

    Learn more
  • Physician Careers at Sanofi

    At Sanofi, physicians like you have the opportunity to collaborate on new ideas and challenge established thinking. Learn about Physician careers here.

    Learn more
  • AI Centre of Excellence

    The AI Centre of Excellence at Sanofi is a unique data-driven team based in Downtown Toronto. We pride ourselves on being data-obsessed and highly focused on using state-of-the-art technologies to drive global impact.

    Learn more
  • Learn more
Two women, seated in an office lobby, working on laptops and talking

What could we achieve together?

Want to join our Global Talent Community? Every Sanofian works on projects that truly make a difference to people’s lives.

What could you achieve? Sign up today and discover our latest opportunities as soon as they’re available.