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Quality Training Lead

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: BioSpace
Apprenticeship/Internship position
Listed on 2026-07-07
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 85000 - 110000 USD Yearly USD 85000.00 110000.00 YEAR
Job Description & How to Apply Below

Job Title

Quality Training Lead

Location:

Waltham, MA

About the Job

Join the engine of Sanofi's mission where deep immunoscience meets bold, AI‑powered research. In R&D, you'll 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 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 miracles of science to improve people's 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 escalated.
  • 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.
  • Liaise with Global Learning Service team to ensure user or administrative issues are resolved in a timely manner.
  • Implement system improvements that…
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