VP, Quality Assurance GMP

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

Position Summary:

Reporting to the Senior Vice President, Quality, the Vice President, Quality-GMP is responsible for developing and managing the global strategy for GMP Quality Management Systems.

This role will lead quality initiatives from clinical trial material release through fully commercialized compounds.

The VP, Quality-GMP will ensure inspection readiness and will be a liaison to Health Authority representatives in the US, Canada, and Europe with GMP and Pharmacovigilance Quality oversight.

Leading a team of 10 professionals, this individual will ensure Taiho Oncology maintains a comprehensive Quality Management System (QMS) and Vendor Management in accordance with regulations and guidelines.

The chosen candidate will be a highly experienced and innovative quality leader with strong experience in late-stage development and commercialization.

Performance Objectives:


* Provides guidance and direction in the development and maintenance of QMS that is GMP compliant with the various health authorities where Taiho Oncology has or will commercialize products.


* Develop and manage GMP best practices for system maintenance, documentation, and processes.


* Lead inspections and audits with health authorities and contract manufacturing partners.


* Provide strategy and direction to contract manufacturing partners with a constant eye to ensuring the partners are fulfilling Taiho Oncology’s expectations.


* Provide global Quality GMP training.

The VP, Quality-GMP will develop and administer a training curriculum for the quality organization and other relevant stakeholders as required.


* Provide global strategy and oversight for pharmacovigilance management and compliance.


* Provide quality data that appropriately assesses risks, opportunities, and potential exposure for the company.

Effectively share/present data to enable business leaders to make fact-based decisions.


* Lead the GMP quality org...