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:
T he 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 Administration
Perform day-to-day data entry and record maintenance for vendor and audit management activities in TWD.
Create and maintain accurate audit and vendor records and supporting documentation.
Track assigned actions, CAPAs, due dates, status changes, and closure activities in TWD.
Perform routine data-quality checks to support the completeness, accuracy, and consistency of records.
Support generation of audit and vendor management data for periodic reporting, metrics, trending, and management review.
Identify data or workflow issues and escalate them to the appropriate Quality stakeholders.
Vendor Quality Management
Execute assigned activities within the risk-based vendor management program.
Coordinate the collection and maintenance of vendor quality documentation.
Support vendor qualification, periodic review, audit, and ongoing oversight activities as assigned.
Track vendor-related quality issues, CAPAs, commitments, and follow-up activities.
Maintain documentation supporting vendor qualification and oversight decisions.
Work with internal stakeholders to obtain information required for vendor quality oversight and escalate vendor quality concerns and trends.
Quality and Compliance Support
Support compliance with applicable GxP requirements, company policies, SOPs, and quality standards.
Assist with preparation and maintenance of procedures, work instructions, and other controlled documents related to vendor and audit management.
Identify potential compliance issues and escalate them through appropriate Quality channels.
Support inspection and regulatory authority activities related to assigned vendor and audit records, as needed.
Participate in cross-functional and global Quality initiatives as assigned.
Education/Certification Requirements:
Bachelor's degree in a scientific, technical, quality, or related discipline
Knowledge, Skills, and Abilities:
Approximately 7 or more years of pharmaceutical, biotechnology, Quality Assurance, auditing, vendor management, or related GxP experience preferred
Experience supporting or managing GxP audits is strongly preferred.
Experience working within an electronic quality management system; TrackWise Digital experience preferred.
Experience working in a regulated pharmaceutical or biotechnology environment.
Working knowledge of GxP requirements and Quality Assurance principles.
Understanding of audit lifecycle management, including planning, reporting, CAPA follow-up, and closure.
Strong organizational and project-management skills, with the ability to manage multiple concurrent activities and deadlines.
Strong attention to detail and ability to maintain accurate and complete quality records.
Ability to identify potential compliance concerns, apply sound judgment, and escalate appropriately.
Strong written and verbal communication skills.
Ability to work effectively with vendors, auditors, Quality personnel, and cross-functional stakeholders.
Problem-solving and risk-analysis skills and the ability to interpret scientific, technical, procedural, and regulatory information.
Proficiency in electronic quality systems and structured quality data management.
The pay range for this position at commencement of employment is expected to be between $131,750- $155,000 annually. 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 annual bonus/incentive comp plans, potential long term incentive plan, 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 a candidate/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.
Location-Princeton,NJ #Location-Pleasanton,CA #LI-Hybrid
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 email People@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.
