Sr. Manager, Quality Assurance GMP Pleasanton, CA, USA Req #425 Tuesday, January 14, 2025 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. Onsite 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, Deviations, CAPAs, Batch Release, Complaints. + Identifies and mitigates risk from within predetermined parameters and ensure that issues are escalated to applicable management + Authors, coordinates, negotiates, and maintains quality agreements between TOI and CMOs. + Assist with GMP audits of contract manufacturing sites and analytical laboratories in compliance with vendor management program processes and procedures. + Author, revise, and review relevant quality internal SOPs for continuous systems improvement. + Prepare Annual Product review reports (as applicable) + Perform tracking and trending and analyze metrics to evaluate and improve processes + Performs Quality assessment associated to batch release and acts as backup for final product release Education/Certification Requirements: + ​​ BA or BS degree required; scientific discipline preferred or comparable experience. Knowledge, Skills, and Abilities: + ​​ 8+ years quality experience within the pharmaceutical industry + Extensive experience operating in a virtual manufacturing environment, being customer service oriented and having in-depth knowledge of pharmaceutical cGMPs and oversight of contract service providers. + Comprehensive working knowledge of federal and international regulatory compliance pertaining to GMP + Ability to make decisions based on phase-specific GMP requirements and appropriate risk assessment + Must understand standards of practice for the manufacture of APIs, solid dosage form drug products, and parenterals. + Applies strong analytical and business communication skills, implements technical solutions to complex problems. + Uses broad expertise and skills to contribute to company objectives and to achieve goals in creative and effective ways. + Must have excellent verbal, written, interpersonal, organizational, and communication skills. + Position requires 15-20% travel. ​ + The incumbent in this position may be required to perform other duties, as assigned. The pay range for this position at commencement of employment is expected to be between $156,400 - $184,000annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #LI-Onsite Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please emailPeople@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records. The incumbent in this position may be required to perform other duties, as assigned. Other details + Job Family Quality Assurance + Travel % 25 + Pleasanton, CA, USA