Sr. Manager, Global Gxp Training

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

This position sits onsite 3 days weekly out of our North Chicago, IL headquarters

Purpose:

AbbVie's quality foundation resides in the Quality Policy & Quality System which includes Compliance Training as an integrated model in which AbbVie systematically defines quality objectives, both strategic and applicable regulatory requirements. This role is responsible for the management of the Global GxP Training Administration Team and for the deployment of training accessibility across all global sites. Responsible for monitoring the effectiveness of the learning management system and maintaining compliance with policies, procedures, and applicable GXP regulations.

Key Accountabilities/Core Job Responsibilities

• Team Leadership

• Oversee the RDQA QS training staff (Training Coordinators and temporary workers).

• Work closely with the Training department members to establish and manage the department budget within 5%.

• Development and cross training team members

• Ensure the team fosters a culture of learning

• Challenge the status-quo, ask questions and be curious about the work we do and how we can be efficient and effective

• Learning Management System (LMS)

• Collaborate with LMS owner to develop plans to optimize learning management system, processes and capacity across the global training organization.

• Collaborate with LMS owner and stakeholders to harmonize processes and tools to confirm the effectiveness of the learning management system as well as training metrics to ensure an optimized training system.

• Proactive monitor and measure LMS activities through intake system (GTAC) and other tools (PowerBI)

• Collaboration

• Interact with departments across R&D to ensure training curricula are specific to department/site needs and ensure that department/site staffs are effectively trained on corporate policies, department processes, GXP procedures, and regulatory training requirements.

• Establish and maintain R&D GxP Training Curricula Management Network to assure harmonized, consistent, and compliant GxP training processes across the respective functions.

• In collaboration with Director, Quality Compliance System Training, establish system governance and standards to ensure learning management systems are leveraging full capabilities while ensuring compliance.

• Maintain close working relationship with various departments and subject-matter experts to enhance the access/delivery of training content and identify opportunities for training system improvement.

• Collaborate with internal IT department and lead the development of LMS and serve as the system subject-matter expert to support and engage training partners.

• Reporting/metrics

• Develop and execute metrics timely providing insights into training outcomes and telling the story of training for R&D Globally

• Lead the description of the training system and associated metrics during regulatory agency inspections.

• Develop relevant dashboards and reporting

• Process / Continuous improvement / Benchmarking

• Ensure all employees have a training plan that covers their basic corporate training and on the job training according to their career path.

• Work with all levels of management to determine core functional competencies required for each position in the organization. Map competencies and roles into the learning management system for role-based training globally.

• Acquire and maintain in-depth knowledge of GXP compliance trends in order to develop strategies for the delivery of high-quality training courses that are relevant to the needs of the organization.

• Execute annual and ad hoc projects with Director, Quality Compliance System Training.

Qualifications

Qualifications/ Experience

• 8 + years' experience leading GxP training curriculum management initiatives and programs for an organization. Previous training experience in the biotech or pharmaceutical industry is highly preferred.

• Experience with providing general supervision to staff members

• Experience managing and implementing learning management systems.

• Experience developing and implementing course curriculums, assessments, testing and other processes to ensure the effectiveness of the learning and development activities.

Education Requirements (degree, certifications, etc.): Include must have and preferred

• BS/BA degree in Computer Information Systems or equivalent, advanced degree desirable

Specific Skills/Abilities

• Must have a firm understanding and application of domestic and international regulatory requirements in the development, clinical, and commercial areas of pharmaceutical products.

• Demonstrate a strong customer orientation working in a site capacity

• General knowledge and understanding of adult learning concepts.

• Exhibits proficiency associated with AbbVie core values and culture imperatives.

Additional Information

Applicable only to applicants