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Job Title: Manager, Quality Operations
Location: Princeton, NJ United States
Position Type: Full Time
Post Date: 10/07/2021
Expire Date: 12/07/2021
Job Categories: Biotechnology and Pharmaceutical
Job Description
Manager, Quality Operations

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 Qual
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.



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

- Bachelorís Degree (BA/BS) or higher
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Contact Information
Contact Email:Mitzi.Sacks@otsuka-us.com
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