Manager, Quality Assurance Operations

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers.

Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission.

Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust.

By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other.

Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients.

Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy.

We invite you to join us.

Hybrid: 3-days per week on-site

Employee Value Proposition

​​​​​​​​​At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most.

This is an opportunity to contribute to Quality Assurance activities in a dynamic, collaborative, and global cross-functional environment.​​

 

Position Summary:

​​​​​​​​​The Manager, Quality Assurance Operations – Vendor & Audit Management is responsible for the day-to-day execution and administration of the Quality Assurance vendor and audit management program under the strategic direction of the Director, Quality Assurance Operations.

The position manages operational audit activities and associated records within TrackWise Digital (TWD), supporting the audit lifecycle from initiation and scheduling through reporting, CAPA follow-up, and closure.

The Manager works with internal stakeholders, auditors, vendors, and Quality colleagues to ensure activities are completed accurately, consistently, and in accordance with applicable procedures and regulatory expectations.

Performance Objectives:

​​Audit Management


* ​Coordinate the operational lifecycle of assigned GxP audits, including vendor audits and other Quality audits.


* ​Schedule audits and coordinate logistics with auditors, vendors, and internal stakeholders.


* ​Support audit preparation by collecting relevant documentation and ensuring required information is available. 


* ​Maintain audit records and track activities through report issuance, response, CAPA management, follow-up, and closure.


* ​Monitor commitments and due dates and follow up with responsible stakeholders to support timely completion.


* ​Escalate significant compliance concerns, overdue activities, and emerging risks to the Director and appropriate Quality leadership.

​TrackWise Digital Admini...