Director, 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 & Documentation Director is responsible for the development, implementation, oversight & maintenance of the Training program. Includes establishment of metrics & Key Performance Indicators to ensure regulatory compliance. Responsible for management of GxP Documents & records per regulatory records management principles.
  • Develop & lead Training efforts related to systems/processes/tools to enhance training performance & maximize the capability to better serve the organization. Develop inter-departmental relationships to support departments & achieve corporate Training compliance.
  • Compliance responsibility for training program. Oversight of the appropriate related training management system & documentation activities. Develop & manage global & regional Training Program initiatives.
  • Provide Strategy for the development & implement of role-based Training curriculums & serve as point of contact for organizational documentation & training compliance needs; including as a key resource / SME for the acquisition & application of learning technologies
  • Provide Strategy for the assessment, design, planning & delivery of training across the organization with specific Quality and Productivity initiatives. Lead organization discussions to identify/implement employee curricula. Liaise with HR/other functions to collaborate for enhancements of the Learning Management System. Partner across organization to streamline & improve Training programs
  • Key function in audits & inspections support with the goal of compliance to regulations & global harmonization. Lead Training & documentation/record retention efforts & outcomes related to inspection readiness & post inspection commitments. Lead Training-related communities of practice & support related gap closure such as training outcomes
  • Lead the implementation of the company's departmental training programs & related documentation records through the implementation of the Learning & Document Management Systems

Program oversight, Quality focus (local/global) and Continuous Improvement
  • Responsible for Training program including oversight for creation, management & lifecycle of training curriculums. Work with global/local teams to proactively identify training gaps & implement the appropriate training strategy/solutions. Escalate training related issues &/or systemic problems with appropriate recommendations/solutions to Sr Management for immediate & long-term resolution in accordance with training best practices
  • Manage the development of Key Quality Indicators & metrics to support the training & document management program and training compliance. Develop, implement, & update Training materials as need to support organizational Quality related activities.
  • Leads training & document management process development/global harmonization of related activities to drive efficiencies & compliance to local and global regulations.
  • Responsible for development & strategy of new hire training & curriculums
  • Maintain current know-how of adult learning methodologies, technologies. Lead train-the-trainer efforts
Cross-functional/Stakeholder Support
  • Provides the appropriate training related risk analysis to key stakeholders (ie. Clinical trial support) to make decisions regarding Training support & compliance. Manage & escalate communications related to the training program across R&D
  • Responsible for training programs related to research and development activities for compliance & ensure training is conducted in accordance with Good Clinical Practice, protocol, EU Directives, MHRA Statutory Instruments, International Conference on Harmonization & Global Policies & Procedures
  • Coach/direct stakeholders on the training program requirements & expected outcomes
  • Main contact for document management in relation to regulatory & legal requirements.
  • Global Training acumen with hands-on experience in development & design
  • Regional & global alignment to drive efficient training practices and harmonization of training programs
  • Ability to influence & motivate colleagues to achieve organizational training needs; including the ability to attract & develop talent
  • Lead blended teams & recommend the appropriate training approaches. Partner with global/regional team to ensure strategic plans, goals & objectives are aligned
  • Ability to forecast, manage & lead organizational training needs & associated budgets
  • Develop new training and document management capabilities
Audits, Inspections and Compliance
  • Liaise with internal teams & functional departments to ensure global coverage to inspection readiness activities. Serve as key contact for training related support for Regulatory Inspections, as necessary including document management in accordance with the local & global requirements
  • Advanced knowledge in the support audit/inspection programs, reporting of audits observations & the translation of related findings into corrective actions plans that mitigate risks to the organization & to patient safety & data integrity
  • Support Document & Record retrieval including SOPs & procedures to support internal audits & inspections
  • Ensure compliance of the training program
Qualifications: 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 10 years of experience in Quality Training/Document management Programs in the pharmaceutical/medical device industry with involvement in regulated clinical trials &/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.