Manager Training and Document Management in Basking Ridge, New Jersey at DSI

Date Posted: 12/27/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:
  • The Training and Documentation manager is in part responsible for the development, implementation, oversight and maintenance of the Training program. With leadership and stakeholder collaboration establishment, of metrics and Key Performance Indicators (KPIs) to ensure the regulatory compliance. Additionally, responsible for management of GxP Documents and records per regulatory records management principles.
  • Support Training efforts related to systems, processes, or tools to enhance training performance and maximize the capability to better serve the organization.
  • Review all training records submitted for completeness and formatting accuracy. Support and lead global Training and Training Program initiatives.
  • Support the development and implementation of role-based Training curriculums and serve as specific support for organizational document and training compliance needs; including as a technical resource or subject matter expert for the acquisition and use of learning technology
  • In consultation with leadership and stakeholders, design, plan and deliver training courses associated with specific Quality and Productivity initiatives, work with Groups/Locations to identify and maintain employee curricula. Liaise with HR and other functions to coordinate and troubleshoot for enhancements of the electronic Learning Management System (LMS).
  • Support audits and inspections with the goal of compliance to regulations and global harmonization. Support Training and documentation/record retention efforts and outcomes related to inspection readiness and post inspection commitments. Lead Training-related communities of practice and support the management of training related deviations/CAPA
  • Support the company's departmental training programs and related documentation records through the administration of the Learning and Document Management Systems. Administer the document management system application.
  • Effectively communicate and influence the outcomes of the decision-making process. Proven ability to manage projects/teams of significant scope and complexity
  • Strong skillset for influencing, being resourceful, managing conflict and negotiating. Works with a sense of urgency and ability to recognize critical deliverables. Ability to lead large teams.
  • Client focused and attention to detail. Demonstrate organizational and emotional intelligence and awareness.
  • Strong critical thinking skills and serve as a positive QA Training ambassador. Demonstrated strong aptitude for facilitating Training development and execution.
  • Ability to successfully plan, adjust, manage and optimize Training resources for the advancement of organizational goals and objectives. Maintain a positive, results oriented work environment, building partnerships within groups & across the global organization
  • Works independently, takes initiative and has a flexible approach to work assignments and other assigned tasks. Strong understanding of clinical research and trial delivery principles and processes for clinical trials
  • Demonstrated strong ability to develop and implement global training strategies
Program oversight, Quality focus (local/global) and Continuous Improvement
  • Support the Training program including creation, management and lifecycle of training curriculums. Work with global and local teams/leaders to identifies, training gaps and implement the appropriate training solutions. Escalate training related issues and/or systemic problems with appropriate recommendations/solutions to Senior Management for immediate and long-term resolution in accordance with Global procedures/practices and training best practices
  • Generate and monitor Key Quality Indicators (KQIs) and metrics to support the training and document management program and overall training compliance. Develop, implement, and update Training materials as need to support organizational Quality related activities.
  • Leads training and document management process development/global harmonization of related activities to drive efficiencies and compliance to local and global regulations.
Cross-functional/Stakeholder Support
  • Provides the appropriate training related risk analysis to key stakeholders (ie. Clinical trial support) to make critical decisions regarding Training support and compliance. Liaise and act as point of escalation for communications related to the training program across R&D, including support of development of enhanced training approaches, as applicable.
  • Support training programs related to research and development activities for compliance and ensure that training is conducted in accordance with Good Clinical Practice (GCP), protocol, EU Directives, MHRA Statutory Instruments, International Conference on Harmonization (ICH) and Global Policies and Procedures, as applicable
  • Serve as the QA Training Subject Matter Expert (SME) for training related activities. As applicable, develop local/global training materials and/or deliver training as appropriate. Serves as a Subject Matter Expert on QA SOPs/Procedures for the training program
  • Act as main point of contact for document management in relation to regulatory and legal requirements. Manage & enforce retention schedules as applicable.
Audits, Inspections and Compliance
  • Liaise with internal teams and functional departments when appropriate to ensure global coverage to inspection readiness activities.
  • Advanced knowledge in the support audit/inspection programs, reporting of audits observations and the translation of related findings into corrective actions plans that mitigate risks to the organization and to patient safety and data integrity
  • Support Document and Record retrieval including SOPs and procedures to support internal audits and inspections
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

  • Bachelor’s Degree or Masters in Life Sciences, Engineering or Sciences
  • At least 7 years of experience in Quality Compliance Training/Document management Programs in the pharmaceutical/medical device industry with involvement in regulated clinical trials and / or technical QA activities (i.e., Clinical Trials/Operations etc).
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.