What are the responsibilities and job description for the Senior Project Manager position at Biotech Partners?
Job Summary:
We are seeking a highly skilled and experienced Project Manager to lead the end-to-end implementation of a global Learning Management System (LMS) for a leading In Vitro Diagnostics (IVD) company. This LMS will serve as a centralized platform to manage training and compliance across all global business units and locations, ensuring regulatory alignment and workforce development.
The ideal candidate will possess strong project management expertise, LMS implementation experience, and a solid understanding of the regulated life sciences environment.
Key Responsibilities:
- Lead the full lifecycle implementation of a global LMS – from vendor selection and requirements gathering to deployment and post-launch support.
- Collaborate with global cross-functional teams including Quality Assurance, IT, HR, Regulatory Affairs, and Business Unit leaders to ensure system design aligns with business, technical, and compliance requirements.
- Manage project scope, schedule, budgets, resource planning, and risk mitigation strategies.
- Develop and maintain detailed project documentation including project plans, timelines, business requirements, UAT plans, and training materials.
- Serve as the primary liaison between internal stakeholders and LMS vendor(s), ensuring timely communication and delivery of milestones.
- Ensure the LMS implementation complies with global regulatory requirements including FDA 21 CFR Part 11, EU MDR, ISO 13485, and other applicable standards.
- Oversee change management efforts and support global adoption, training, and onboarding for end users.
- Monitor and report on project progress to senior leadership and project steering committees.
- Coordinate data migration, system integration, and validation testing activities in partnership with IT and QA teams.
- Establish governance frameworks, standard operating procedures (SOPs), and scalable workflows for ongoing system sustainability and support.
Required Qualifications:
- Bachelor’s degree in Project Management, Business, Life Sciences, Information Systems, or a related field. PMP or similar certification preferred.
- 5 years of project management experience, including at least 2 years leading LMS implementations (Cornerstone, Saba, SuccessFactors, etc.) in a global, regulated environment.
- Strong understanding of IVD or medical device industry standards and quality systems, including knowledge of regulatory training compliance (FDA, ISO, EU MDR).
- Experience managing cross-functional and international teams across time zones.
- Demonstrated success in driving large-scale systems implementation projects on time and within budget.
- Excellent communication, stakeholder management, and vendor coordination skills.
- Familiarity with system validation (CSV), change control processes, and GxP requirements.
- Strong analytical and problem-solving skills with attention to detail.
Preferred Qualifications:
- Experience integrating LMS platforms with HRIS, ERP, or other enterprise systems.
- Working knowledge of adult learning principles and training content delivery models.
- Prior experience supporting enterprise digital transformation initiatives.
