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Quality Continuous Improvement Specialist

Sanofi

Sanofi

Quality Assurance
Framingham, MA, USA
Posted on May 19, 2025

Job Title: Quality Continuous Improvement 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.

Quality Assurance (QA) is responsible for quality oversight of operations at Sanofi MA BioCampus facilities. QA’s main responsibility is to ensure adherence to cGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities. The QA Process-Centric Unit (PCU) is a team that is responsible for the 24hour QA performance of a defined manufacturing area to support operations and drive continuous improvement.

The Continuous Improvements (CI) Specialist role is to drive industrial excellence to achieve the PCU’s strategic objective and performance ambition. The CI Specialist brings a high level of expertise and leadership in lean methodology, industrial performance, digital solutions, transformation and change management.

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:

The main impact expected for the CI Specialist is to support the PCU to reach the targeted level of performance related to the area Strategy and glidepath.

  • Continuously analyses the performance of the PCU and supports the performance & continuous improvement actions.

  • Contributes to the definition of the PCU's trajectory with the PCU Manager and other CI Specialists in line with the site's compelling business needs.

  • Build, maintain and govern SMS standards used by the PCU to drive performance.

  • Improve data governance at PCU level.

Performance

With the PCU Lead and APU SMS member, develop the PCU's performance plan (duration less than 1 year, action carried out by the PCU and specific to the PCU).

  • Collects and analyses performance data directly from Gemba or through digital systems (deviations from standards, improvements, etc.)

    • Performs the cost analysis and confirms the capture of gains

    • Monitors the performance of actions identified and the achievement of outcomes, managing roadblocks & risk management

  • Ensures CI initiatives are delivered on-time and within established budgets, while delivering the committed value to the PCU performance

  • Leads the PCU's continuous improvement meetings

  • Provide leadership and coaching to ensure that PCU Performance deliver well defined and quantified outcomes

  • Through a strong Gemba presence, conducts regular Gemba's to coach the teams on waste identification and perform confirmation processes.

  • Contributes to the network with the community of continuous improvement specialists to align practices and advance SMS standards

Expectations

  • Achieve SMS certification intermediate level within 6 months

  • Ability to analyze and make data driven proposals.

  • Ability to coordinate multiple CI programs

  • Capability in data analysis and diagnostics

  • Good knowledge of plant operations

  • Strong communication skills

  • Ability to lead teams in a matrix organization

  • Ability to influence at multiple levels within an organization

  • High level of autonomy

  • Problem Solving-solving skills

  • Strong Computer Literacy

About You

Basic Qualifications

  • Minimum of 5 years of experience in a Pharma/Bio setting, preferably within a GMP manufacturing setting

  • Bachelor’s degree in business, Engineering, Operations, Biology, Chemistry or other similar relevant disciplines

  • Fluent English spoken and written

Preferred Qualifications

  • Experience in team leadership

  • Experience in project management

  • Experience or certification in operational excellence, such as Six Sigma Green Belt or Black Belt

  • Hands-on experience in Lean Manufacturing and experience in leading/supporting transformation programs

Special Working Conditions

  • Ability to gown and enter clean rooms.

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.

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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.