The Associate Director, Global Quality Operations role is focused on partnering with the leadership team to drive the digital information roadmap for the Global Quality department. This individual will be responsible for improving operations by recommending, supporting, and implementing continuous improvement activities and process improvements to optimize results and improve quality of delivery by following quality best practices. The individual will establish proactive measures as well as preventative ones to further advance the overall health of the organization.
The Associate Director, Global Quality Operations has several duties and responsibilities. Some of these include:
- Provide oversight for developing and establishing a Data Governance strategy for Global Quality.
- Support Global Quality in establishing a data council for Quality Systems.
- Provide oversight for creating policies and procedures for effective data governance and data management.
- Establish rules and procedures for data sharing and ingestion in Quality Systems.
- Lead a document digitation initiative.
- Lead an effort to modernize the document management system while ensuring global alignment and process harmonization.
- Partner with and support the Global Quality Operations leadership team to achieve the goals and objectives of the Global Quality department.
- Collaborate with key stakeholders across Global Quality to identify new solutions for existing challenges and establish a roadmap to drive process improvement and digital transformation.
- Support global organizational initiatives such as harmonization of processes and adherence to best practices.
- Interact with the various business groups within the Global Quality department and support their process improvement and technology needs by partnering with IT to implement solutions that support their functions.
- Work collaboratively, negotiate, and engage with key stakeholders to facilitate delivery and compliance with the quality strategies and governance processes
- Provide frontline business input support for requirements on processes, tools, implementations, and change management activities
- Work with the Global Quality department to gather and document requirements while ensuring global alignment.
- Support the Global Quality users with system access management needs and improve User Access Management processes.
- 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.
- Develop GQ system training strategy from planning to delivery of modules, while ensuring global user community expectations are met.
- Partner with project teams and relevant stakeholders on business systems identification, validation, implementation, control, and continuing enhancement to achieve business objectives.
- Ensure thorough review and/or approval of Global Quality validation/qualification documentation, plans, reports, and other documentation, as applicable.
- Prepare reports by collecting, analyzing, and summarizing data.
- Produce written reports and make presentations.
- Attend various meetings and communicate instructions and actions.
- May act as Quality Trainer for assigned processes, tools and software, as applicable.
- Manage experienced specialist employees and contract workers, to includes assigning their work and overseeing their activities.
- Establish operational objectives and work plans and delegate assignments.
- Perform administrative tasks for the Global Quality Operations team such as submitting requisitions and managing contracts.
- Mentor peers and others.
Knowledge/ Experience and Skills:
- Minimum of 5 years industry related experience is required.
- Applicable experience in healthcare technology is strongly preferred.
- Successful track record of leadership and timely delivery of innovative business deliverables.
- Strong communication, interpersonal and alliance management skills; possessing the ability to credibly, knowledgeably, and effectively represent and communicate initiatives to internal and external stakeholders.
- Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science and research to increase Otsuka's competitive edge.
- Ability to Influence stakeholders across functions.
- Ability to build partnerships with other functional leads.
- Ability to work effectively in a matrixed, multi-cultural, collaborative, and self-directed environment.
- Strong project management experience, with the ability to successfully engage in multiple initiatives simultaneously.
- Advanced analytical skills, and general understanding of the drug development and regulatory process is required.
- Knowledge of GxP areas.
- Exceptional oral and written communication skills.
- Working knowledge of Document Management Systems, preferably Veeva Quality Docs.
- Experience with software applications that will be regularly used (in particular: Excel, MS Project, SharePoint, PowerPoint and MS Teams).
- PMP certification
- Lean six sigma
- Demonstrated contributions that have helped innovatively transform processes, technology, roles, organizational activities and collaborations
- Working knowledge of 1 or more of the following systems
- Quality Management System
- Learning Management system.
- Master's degree or higher
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.Statement Regarding Job Recruiting Fraud Scams
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