Sr. Manager, LMS & Training

The Sr. Manager, Global Learning Management Systems and Training is a global role with a broad cross functional and company interface responsible for providing a globally aligned training and learning management framework within Seqirus. This role will partner with all sites and functions to implement a standardized process for managing all aspects of GXP training and system administration throughout its lifecycle.

This role leads two functional streams as the Global Business Process Owner (BPO) for the Learning Management System (LMS) and Global BPO for the Training Program. 

This role manages review, approval, and administration of Change Controls, Deviations/Corrective and Preventative Actions, and Inspection Responses related to the LMS and Training Program while working directly with key stakeholders to assure compliance of Seqirus programs to phase-appropriate GxPs, global legal/regulatory requirements and applicable global Seqirus Quality Policies.

This role leads and prioritizes strategic solutions that are flexible, risk-based, and scalable, and drives efficiencies while ensuring that the training management process is standardized and aligned across Seqirus, and where appropriate aligned with CSL. This includes developing and directing training management policy, procedures, and system administration for the organization, as well as the regular implementation of fully validated system upgrades and enhancements.

Principal Accountabilities

Owns the Global Training Program

• Ensures the Global Training Program reflects business requirements enabling compliance with applicable policies, procedures, and/or legal requirements.

• Coordinates Global training strategies which develop the skills and knowledge of employees.

• Drives training creation and delivery that is benchmarked for effectiveness.

• Implements innovative learning and development technologies to shape a culture of learning across the Global business.

• Leads the strategy for development of appropriate documented policies and procedures including communication and training plans to support rapid stabilization upon transition/roll-out across the enterprise.

• Collaborates with the Global business to define, monitor, and report on training-related Key Quality Indicators (KQIs) and other quality-related metrics.

Owns Global Learning Management System (LMS)

• Ensures LMS functions reflect business requirements enabling compliance with applicable policies, procedures, and/or legal requirements.

• Represents the entire Seqirus organization with respect to LMS change control approval, communication of needs to IT, steering committee engagement, and resourcing to support development

• Leads LMS annual management review and maintains the 5-year strategic roadmap for continuous system improvement, in conjunction with I&T.

• Partners with I&T as required in support of Computer System Validation

• Ensures only approved users have appropriate access within the system by approving access and regularly reviewing existing user access levels.

• Creates, revises, and periodically reviews LMS procedures, work instructions, and training programs.

• Drives generation of standardized metric and trending reports for system usage which can be used by all sites and functions to measure performance and compliance.

• Expert in the electronic system, each individual system role, and how those roles are trained.  Can serve as LMS Administrator and Trainer.

• Utilizes understanding of the LMS and the integration between LMS and the Document Management System to build, maintain, and support business processes.

Drives and monitors the ongoing Global implementation LMS upgrades, enhancements, and repairs

• Directs and develops business requirements and processes required to build/maintain/improve the system (includes key stakeholder engagement).

• Collaboratively works with internal employees, external vendors, and consultants to effectively implement solutions for the organization.

• Partners with I&T technical teams throughout development to ensure business defined acceptance criteria is achieved for all system changes and projects.

• Provides subject matter expertise and recommends risk mitigation strategies for system functional risk assessments.

• Engages with all functions to develop user requirements specifications for electronic systems that are fit for purpose, GxP Compliant, and will deliver a cost-effective business benefit.

• Oversees and ensures high quality computer system validation and system development through area expertise and management of global team. Includes review and/or approval where applicable of the following: functional risk assessments, user requirements specifications, I&T change controls, migration plans, user acceptance testing (scripts, executed runs, and defects/resolution) testing and migration summary reports, and other Validation/QMS documentation for LMS.

Manages direct reports and provides leadership to indirect reports

• Manages a global team of both experienced professionals and managers.

• Ensures all performance management processes are complete in line with business requirements.

• Supports effective organizational change both through organizational design and change management ensuring teams buy in to strategy.

• Cultivates talent and creates development opportunities for staff.

Oversees DR/CAPA, Change Control, Inspection Readiness, and Continuous Improvement for LMS

• Investigates deviations and owns change controls and CAPAs related to LMS or the department.

• Supports site and function audit preparations with respect to system functionality or the training program. 

• Reviews audit reports, supports responses to findings, and takes appropriate actions to ensure GxP compliance.

Partners with I&T for continuous improvement efforts and on-going maintenance of LMS. 

• Partners with I&T, I&T Compliance, QAIT to build bridges and proactively improve cross-business collaboration.

• Escalates issues when needed to Upper Management both within and outside of department line.

• Collaborates with I&T team to conduct research and analysis on new and innovative enhancements and to resolve technical issues.

• Drives proactive communication of ongoing, daily support, and issue resolution.

Minimum Requirements

• Requires a bachelor’s degree, preferably in relevant scientific discipline. (Relevant experience in pharmaceutical or related regulated field will be considered.)

• Requires minimum 7+ years’ experience in management or supervision, training and development, and project management.  Significant exposure to Good Manufacturing Practices (cGMPs), and advanced knowledge of Quality Systems requirements. 

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.