Job Summary

The Associate Director, QMS Training Management (Global R&D & PV QA) reports to the Head Global Quality Management System (QMS) (Americas/Europe) and is responsible for managing and supporting the implementation of the global GCP/GVP/GLP training and onboarding strategy, training development and delivery, and measuring training effectiveness and compliance.

The Associate Director will play a global training lead role in supporting the global R&D, PV, MA, and QA organizations to ensure the GCP/GVP/GLP training and communication strategies, processes, procedures, programs, and systems comply with applicable GCP/GVP/GLP standards, relevant regulatory requirements, and applicable Daiichi Sankyo policies and procedures.

Job Description

Training Program Management: Manage the creation and implementation of training courses as identified in annual training plans, role-based training curricula, GCP/GVP/GLP computer systems training plans, and other projects as needed in collaboration with functional leaders, SMEs/SOP authors, training vendors, and regional/local training leads.

Assess training needs and determine optimal training delivery approach, training audience, and communication strategy in a training implementation plan with global/local training leads, SMEs/SOP Authors

Facilitate identifying training content for development and delivery with functional leaders and SMEs/SOP Authors.

Oversee/manage the creation of training courses in various modalities, including blended approaches (e.g., instructor-led training, eLearning, etc.) with SMEs/SOP Authors, vendors.

Engage with and manage external training vendors as required to ensure training content availability and delivery.

Create, implement, and maintain the global GCP/GVP/GLP New Employee Onboarding program that ensures effective functional onboarding of GCP/GVP/GLP resources by partnering with functional leaders and representatives.

Oversee/manage the global and local learning management system activities, including role-based training curricula development and administration, training and roster registration/assignment, course creation and availability, and training histories.

Qualify GCP/GVP/GLP SMEs identified to deliver instructional design/adult learning principles training by implementing the SME Train-the-Trainer qualification program.

Stay current with industry-leading training practices and incorporate them into GCP/GVP/GLP training.
Partner with Global QA leaders, functional leaders, or their SMEs to incorporate CAPAs and lessons learned into training activities.

Qualifications

Education

• A Bachelor’s Degree in a science-related discipline required. A higher-level degree such as a Master’s Degree is preferred

Basic Requirements 

7 or more years of professional pharmaceutical industry experience managing GxP learning development activities in the pharmaceutical or biotech industry, or equivalent experience is required.

Must have in-depth knowledge of Quality Management Systems and related GxP principles:

Broad understanding of global expectations of Regulatory Health Authorities

Extensive knowledge with managing global Training Programs, Development, Implementation, Management, including System management application

Strong interpersonal and prioritization skills with demonstrated ability to build collaborative relationships

Excellent problem solving and decision-making skills. Skilled at conflict resolution / negotiation.

Organization awareness (e.g., interrelationship of depts., business priorities), including significant experience working cross-functionally and in global teams across different regions of the world

Experience with participation in regulatory inspections presenting or defending subject matter area in audits or regulatory inspections.

Understanding and familiarity with FDA, EMA, MHRA, and other European and international regulatory requirements, guidelines