Director, Quality Assurance PV

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

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 exciting opportunity to support and contribute to the continuous building of a unified Quality Assurance function in a dynamic, collaborative, and global cross-functional environment.

Position Summary:

The Director, Quality Assurance, (Pharmacovigilance [PV]) reports into the Sr.

Director, Quality Assurance, PV and is responsible for partnering with the Sr.

Director of QA, PV and PV colleagues to assure their strategy and execution ingrains quality and compliance across all aspects of product safety across clinical development and post-marketing surveillance.

Additionally, this position would represent QA to identify risks, resolve issues, and escalates appropriately to ensure the safe use of products globally.

This individual should demonstrate a high level of independent quality judgement and acumen and be able to work.


* Coordinate and assist in identifying policy development, promoting and assessing compliance of Taiho "customers" with regulations, guidelines, and operating procedures as applicable.


* Assist in global and local SOPs preparation and maintenance within the business unit and harmonization of worldwide operating procedures, as applicable.

Liaise with Business Development and operations.


* Provide QA support end-to-end of PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment.


*  Identify possible compliance issues and review and approve Deviations, Corrective Actions and Preventive Actions (CAPAs).


* Responsible for supporting inspection readiness related to GVP.


* Support Taiho Global GXP operations.


* Review and contribute to Safety Data Exchange Agreements (SDEA’s), Pharmacovigilance Agreements (PVA’s), or othe...