Quality Training Lead

BioSpace

Waltham (MA)

On-site

USD 120,000 - 160,000

Full time

24 hours ago
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Benefits offered by this job

Health benefits
14 weeks parental leave
Career growth opportunities
Global mobility

Job summary

Sanofi in the U.S. seeks a Quality Training Lead for the Waltham, MA area to drive GMP-aligned training programs and regulatory-compliant content across the organization.

You will lead the Global Training Center, partner with VR&D and M&S teams to harmonize practices, and implement scalable training initiatives that protect product quality and patient safety. This role offers career growth, a collaborative environment, and access to advanced AI-powered learning tools within a global biopharma

Qualifications

  • Bachelor's degree in Science or related field (required).
  • Minimum 5 years of experience in training, LMS, quality, compliance, documentation, or QA.
  • Educational experience will be considered.

Responsibilities

  • Represent the Global Training Center at the senior level to ensure continuity and alignment across global operations.
  • Own end-to-end governance of training matrices, plans, and content, aligned with GMP and regulatory standards.
  • Establish and monitor KPIs to identify compliance gaps and lead corrective actions.
  • Guide SMEs in creating and revising training materials, reviewing content for compliance.
  • Lead high-visibility pilot projects and global training initiatives to set benchmarks for excellence.

Skills

Training expertise
Learning management
Quality assurance
Regulatory compliance
Documentation

Education

Bachelor's degree in Science or related field

Tools

LMS

Job description

About The Job

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

Job title

Quality Training Lead

  • Location: Waltham, MA
About The Job

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.

Basic Qualifications
  • Bachelor's degree or equivalent.
  • Minimum 5 years of experience in one or more of the following areas: training, learning management, quality, compliance, documentation, or quality assurance.
  • Educational experience will be considered.
Preferred Qualifications
  • Bachelor's degree in Science or related fields.
  • Hands-on experience with Learning Management Systems (LMS).
  • Quality Assurance (QA) or compliance experience in pharmaceutical, biotech, or related industries.
  • Familiarity with GxP training requirements.
Main Responsibilities

Leadership & Strategic Contribution:

  • Represent the Global Training Center at the senior level, acting on behalf of the Training Center leadership as needed to ensure continuity and strategic alignment across global operations.
  • Champion a culture of continuous improvement by actively contributing to Communities of Practice sharing expertise, elevating best practices, and driving innovation in training methodologies across the organization.
Training Management & Compliance
  • Own the end-to-end governance of training matrices, training plans, and learning content for the Global Training Center, ensuring full alignment with GMP requirements, regulatory standards, and evolving business needs.
  • Establish and monitor key performance indicators (KPIs) to proactively identify compliance gaps, assess training effectiveness, and lead targeted corrective actions before issues escalates.
  • Collaborate with VR&D departments across global sites to harmonize training practices, ensuring consistency, regulatory alignment, and a unified compliance culture across geographies.
  • Partner with the Head of Global Training Center to design and execute strategic initiatives that simplify, standardize, and continuously strengthen training programs at scale.
  • Serve as the training compliance subject matter expert (SME) for quality systems including Deviations, CAPAs, and Change Controls providing authoritative guidance that protects product quality and patient safety.
  • Guide and support SMEs in the creation and revision of training materials and assessments; review and approve content to ensure full compliance with established training procedures and regulatory expectations.
  • Lead high-visibility pilot projects and global training initiatives that set new benchmarks for excellence and position Sanofi as an industry leader in compliance-driven learning.
Customer Support & Audit Readiness
  • Serve as the training SME to departments and functions, guiding them in developing compliant training materials, matrices, and iLearn curricula.
  • Act as the critical interface between the LMS team and operational departments (M&S, HSE, and others). Drive organizational compliance through the design and delivery of actionable training plans.
  • Support audits and self-inspections with confidence providing pre-audit documentation, responding to inspector requests, and demonstrating iLearn expertise.
  • Provide strategic guidance to improve training compliance across VRD, identifying systemic issues and implementing sustainable solutions.
  • Educate and empower customers to navigate iLearn effectively, building a culture of compliance ownership.
LMS System Administration & Compliance Oversight
  • Oversee and provide compliance guidance to the GTC team of Decentralized Administrators for VR&D, ensuring the iLearn platform maintains the highest standards of compliance and data integrity.
  • Liase with Global Learning Service team to ensure user or administrative issues are resolved in a timely manner.
  • Implement system improvements that enhance compliance tracking.
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 its 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.
  • Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
  • Help improve the lives of millions of people globally by making drug development quicker and more effective.
  • Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

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

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.

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