Lead regulatory compliance and audit response as a quality management expert in the pharmaceutical industry, driving efficiency and quality improvements in manufacturing processes
Job Summary
Lead regulatory compliance and audit response as a quality management expert in the pharmaceutical industry, driving efficiency and quality improvements in manufacturing processes.
Establish a comprehensive quality management framework including internal/external audit support, system evaluation, SOP development, and risk assessment to ensure product quality and patient safety.
Contribute to the future of pharmaceutical manufacturing by developing innovative solutions for quality management challenges, leveraging continuous learning opportunities and ensuring product safety, performance, and regulatory adherence throughout the product lifecycle.
Matching Summary
Lead regulatory compliance and audit response as a quality management expert in the pharmaceutical industry, driving efficiency and quality improvements in manufacturing processes.
Skills & Requirements
Must-have
Quality Management Systems
Regulatory Compliance
Audit Support
GMP Standards
SOP Creation and Implementation
Nice-to-have
Continuous Improvement Culture
Client Collaboration
Innovative Solutions
Product Lifecycle Assurance
Key Requirements
5+ years of CSV or Quality Management experience in Pharmaceutical Industry
Deep knowledge and practical experience of GMP regulations
Audit response and regulatory authority communication experience
Excellent analytical and project management skills
Business-level Japanese and English communication skills