Otsuka Pharmaceuticals Hiring for Manager, Quality Operations Job at Remote Full Time

Job Summary

This role is focused on driving the quality information roadmap across each of the solutions, e.g. Trackwise, GQEDMS, GQ Data Studio, Compliance Wire within Global Quality. Intended to drive a digital information roadmap to establish proactive measures as well as preventative to further advance the overall health of the organization.

Job Description

• Partner with and support assigned functional groups, departments and regions to achieve the goals and objectives of the Global Quality Team
• Interact with the various business groups within the Global Quality team and support their technology needs by partnering with IT to implement solutions that support their functions.
• Plan and execute Change Management activities to ensure successful completion of technology and process improvement initiatives.
• Plan and execute Communication Management activities to ensure successful communication of technology and process improvement changes to all relevant stakeholders.
• Maintain on-going communication with relevant stakeholders for project related activities and tasks that support the Global Quality team.
• Work with key stakeholders from the Global Quality team to ensure training plans and materials are created for new systems and for change request
• Represent the interests of the Global Quality team to identify solutions for their process improvement needs and their technology needs
• Work with the Global Quality team to gather and document requirements to provide solutions to support their needs
• Support the Global Quality Operations collaborates with key stakeholders across functional area to identify new solutions for existing challenges and establish a roadmap to drive process improvement and digital transformation
• Partner with project teams and relevant stakeholders on business systems identification, validation, implementation, control and continuing enhancement to achieve business objectives
• Provide frontline business input support for requirements on processes, tools, implementation and change management
• Ensure thorough review and/or approval of Global Quality validation/qualification documentation, plans, reports and other documentation, as applicable
• May act as Quality Trainer for assigned processes, tools and software, as applicable
• May act as Quality Representative for project information dissemination to internal stakeholders, alliance partners and other company vendors, as applicable.

Qualifications

Required:

• 5-10 years project management support experience
• PMP Certification
• Knowledge of GxPs and Quality Management Systems
• The candidate should have exceptional oral and written communication skills and be knowledgeable with software applications that will be regularly used (in particular: Excel, MS Project Server, SharePoint and PowerPoint).

Experience Preferred:
Supporting and managing a Trackwise Digital Implementation is preferred

• Lean Six Sigma certification
• Demonstrated contributions that have helped innovatively transform processes, technology, roles, organizational activities and collaborations
• Working knowledge of 1 or more of the following systems
  • Document Management System
  • Learning Management system.

Educational Qualifications

• Bachelor’s Degree (BA/BS) or higher