Job Description

Exciting Opportunity for Quality Professionals at Intech Biopharm (TAIWAN)

If you are passionate about Creating, Sustaining and Leading a Quality Culture in a Pharmaceutical manufacturing site and meet the following requirements, then feel free to send across your updated resume along with a short summary of your accomplishments to hr@intechbiopharm.com.

Please add “Application for Lead Quality Role” in the subject line

Responsibilities
*Lead the establishment, maintenance, and continuous improvement of the GMP Quality Management System in compliance with PIC/S GMP, USFDA, ICH, and other global regulations
*Develop, implement, and review Quality policies, SOPs, and quality standards to ensure regulatory compliance
*Oversee deviation management, CAPA, change control, risk assessment, and management review meetings
*Plan and execute internal audits and supplier audits to ensure supply chain quality compliance
*Collaborate closely with Production, QC, R&D, and Regulatory Affairs to support product development, technology transfer and commercialization
*Lead, mentor and develop the Quality team to build strong compliance culture and capabilities
*Act as the primary contact with regulatory authorities (TFDA, USFDA, EMA, etc.) during inspections and regulatory communications
*Be accountable for defining quality strategy, ensuring global regulatory compliance, and safeguarding product quality and patient safety across all manufacturing operations

Requirements
*Master’s degree or above in Pharmacy, Chemistry, Biology, or related field
*Minimum 12-15 years of experience in Quality Assurance function in pharmaceutical industry, with at least 5 years in management role
*In-depth knowledge of PIC/S GMP, ICH Q-series, FDA/EMA regulations
*Hands-on experience in internal audits, supplier audits, and direct interaction with health authority inspections
*Strong leadership, cross-functional collaboration, and decision-making skills