Senior Specialist, Training

Role Summary

The Senior Training Specialist manages planning, coordination, implementation, evaluation, and maintenance of GxP training curricula for R&D. This role collaborates with leadership and stakeholders to create and manage fit-for-purpose GxP training that aligns with personnel qualification requirements and maintains regulatory compliance.

Responsibilities

• Stakeholder Collaboration: Work closely with leaders and other stakeholders to ensure new user roles and GxP Training curricula are accurate and relevant.
• GxP Training Curricula Oversight: Create, manage and review new and established GxP Training curricula continuously throughout the year, inclusive of CORE GxP Training curricula(s).
• Continuous Improvement: Evaluate existing GxP Training curricula and make recommendations for enhancements based on user roles, organizational changes and feedback.
• Quality Assurance: Understand AbbVie's Quality System and apply the knowledge when executing activities. Ensure all GxP Training curricula comply with regulatory requirements and quality standards.
• Assessment & Evaluation: Establish assessment methods to evaluate the effectiveness of GxP Training curricula and use data to inform improvements.
• Change Management: Maintain organizational changes and hierarchy changes in the Learning Management System (LMS).
• Learning Impact Assessments: Assess how new documents might impact GxP curriculum and GxP training plans.
• Integrations: Work with leadership to ensure employees moving into new roles due to an integration have the required GxP training and GxP curriculum for their role.
• GxP Training Metrics: Develop, maintain, and update monthly and quarterly training metrics reports, capturing and integrating organizational changes, and ensuring accurate data collection. Ensure alignment and integration with validated systems and EDC.
• Audits/Inspections: Represent Global GxP Training during regulatory inspections, audits and process improvement initiatives.

Qualifications

• Bachelor of Science (BS) is preferred
• 2+ years of learning management system experience, Compliance Wire is a plus
• Advanced knowledge in LMS (reports, GxP Training curricula, user groups)
• Strong written and excellent oral communication skills
• Ability to independently manage multiple tasks/assignments, meet deadlines and act with flexibility and initiative to thrive in a dynamic environment of rapidly changing needs
• Ability to effectively interact and develop constructive and cooperative relationships with subject matter experts and other business partners exhibiting professional maturity
• Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects, both working independently and within a team
• Demonstrate analytical and critical thinking skills
• Demonstrate leadership by proactively identifying, managing, and implementing ideas for improvement