Quality Training Lead
Sanofi · Waltham, MA · 3 wk ago
HybridQuality AssuranceFull-time
About the role
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.
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
- 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 escalate.
- 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 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 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.
- 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.