Sr. Manager, 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

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 (GMP) function in a dynamic, collaborative, and global cross-functional environment. 

Position Summary: 


* ​​The Sr Manager, QA is responsible for the quality oversight of contract manufacturers that support Taiho’s products (either in clinical phase or commercial).

Depending on the stage of the product’s lifecycle, the person will be responsible for the product quality (which may include drug substance, drug products, and packaging/labeling) contract manufacturers while developing and maintaining relationships.  Leading by influence, the individual must be well organized and have excellent oral and written communication skills to effectively interact with internal and external parties to ensure quality compliance needs are met in a timely manner.  Responsible for the QA oversight of day-to-day GMP Operations within Taiho and at CMOs.​ 

Performance Objectives: 


* Acts as the primary QA contact and manages quality responsibilities related to assigned cGMP manufacturers for a Taiho product/program and maintains compliance with global regulatory requirements and applicable filings. 


* Performs the quality review of GMP documentation which may include (but not limited to): batch records (master and executed), deviations, investigations, change controls, CAPAs, complaints, protocols and reports (stability, validation (method and/or process)), and/or regulatory submissions


* Be the Quality Assurance representative in internal cross functional meetings, external vendor team meetings, and with Taiho affiliates as needed.


* Opens and maintains internal GMP records for Change Controls, Dev...