Site Quality Head
7 days ago
**Join us as we elevate standards and redefine quality assurance in our dynamic manufacturing environment. Lead our team to new heights as our Site Quality Head and drive excellence every step of the way.**
**Reporting to the VP of Quality, you will speahead our site's quality initiatives,ensuring uncompromising standards and driving continuous improvement across all operations while cultivating a **"Quality Always" **mindset throughout the organization.
**Responsiblities**:
- Lead the Quality Assurance team, covering operational quality, quality systems, and compliance, along with managing the Quality Control team. Responsible for staffing, training, and fostering the development of the Quality organization.
- Supervise all GXP activities at the Lotus Taiwan site, overseeing manufacturing, testing, release, facility, and utilities to maintain compliance with cGMP.
- Ensure adherence to regulatory requirements, including US FDA, EU, PIC/S, and TFDA standards, and drive continuous enhancement of Lotus Quality systems.
- Conduct and oversee quality audits, both internal and external, and manage responses. Act as the host for customer and regulatory audits at the Lotus Taiwan site.
- Serve as the primary interface with Quality Personnel and external stakeholders on quality-related matters.
- Manage batch disposition, recalls, and complaints, including handling product quality complaints and adverse events.
- Direct the process of new product introduction, technology transfer, and support for product registrations.
- Oversee supplier and third-party management, ensuring compliance with quality standards, particularly for contract manufacturing and laboratories.
- Handle the budget, headcount, and capital expenditure of the Quality department.
- Provide quality oversight for Good Distribution Practice in the Lotus Taiwan commercial operations.
- Manage quality aspects for in-licensed products in the Taiwan market.
- Fluency in Mandarin is a must to communicate to the manufacturing environment.
**Requirements**:
- Strong knowledge of Goods Manufacturing Practices (GMP) and other regulatory requirements including US FDA, EU PIC/S and TFDA regulations.
- Proven experience in managing GXP activities, including manufacturing, testing, release, facility and utilities.
- Experiece in leading and managing quality audits, both internal and external and responding to audit findings.
- Excellent understanding quality systems and continuous improvement methodologies.
- Demostrated ability to manage and resolve product quality complaints, adverse events, and recalls.
- Experience in managing budgets, headcount, and capital expenditure within a quality department.
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