Manager, Quality Assurance Operations
Taiho Oncology, Inc.
Summary
The 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.
Job description
Position Summary
The 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.
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.
Requirements
- Bachelor's degree in a scientific, technical, quality, or related discipline
- Approximately 7 or more years of pharmaceutical, biotechnology, Quality Assurance, auditing, vendor management, or related GxP experience
- Experience supporting or managing GxP audits
- 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
- Strong attention to detail
- Ability to identify potential compliance concerns 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
- Proficiency in electronic quality systems and structured quality data management
Benefits
- Medical insurance
- 401(k) eligibility
- Paid time off
- Vacation
- Sick time
- Parental leave
- Annual bonus
- Incentive compensation plans
- Long term incentive plan
Company overview
Taiho Oncology, Inc. is a specialized oncology pharmaceutical company focused on developing and commercializing innovative oral anti-cancer therapies. Founded in 2002 and headquartered in Princeton, New Jersey, the company operates as a subsidiary of Taiho Pharmaceutical Co., Ltd., which is part of Otsuka Holdings Co., Ltd. Taiho Oncology's mission is to improve the lives of patients with cancer, their families, and caregivers through the advancement of novel cancer treatments. The company specializes in orally administered anti-cancer agents targeting various tumor types, with a robust pipeline of small molecule clinical candidates for both solid tumors and hematological malignancies. Taiho Oncology has established a world-class clinical development organization and built a commercial business in the United States, while also overseeing its parent company's European and Canadian operations. The company's approach focuses on bringing novel technology to cornerstone chemotherapies for a wide range of tumor types, including colorectal cancer and other solid tumors. With approximately 201-500 employees, Taiho Oncology maintains operations in Princeton, New Jersey and Pleasanton, California, demonstrating its commitment to advancing oncology research and patient care through innovative pharmaceutical development.