Pharmaceutical Company: Quality Head

【Client Description】

我們的客戶為台灣領先的製藥集團，產品涵蓋學名藥、專利藥，並積極拓展國際市場。公司注重品質與合規，現誠徵資深主管全面領導品質體系。

• Our client is a leading Taiwan-based pharmaceutical group with a strong portfolio in generics, patented drugs. The company emphasizes quality and compliance and is expanding internationally, now seeking an experienced leader to head its quality organization.

【Candidate Profile】

• 大學以上藥學、化學、生命科學或相關領域，碩博尤佳

• 十年以上製藥業品質管理經驗，至少五年主管資歷

• 熟悉 GMP/GDP 與台灣及國際法規 (ICH、FDA、EMA)

• 具備稽核經驗，能應對主管機關檢查

• 英文流利，具跨國溝通與領導能力

• Bachelor’s degree or above in Pharmacy, Chemistry, Life Sciences, or related fields; advanced degree preferred

• Minimum 10 years of pharmaceutical quality management experience with at least 5 years in leadership

• Strong knowledge of GMP/GDP and regulatory requirements (ICH, FDA, EMA, TFDA)

• Experience in audits and regulatory inspections

• Fluent in English with proven leadership and communication skills

【Responsibilities】

• 全面領導品質管理部門，確保 GMP 與 GDP 合規運作

• 監督產品放行、變更控制、偏差調查與 CAPA 活動

• 主導內外部稽核，確保工廠及供應鏈符合法規要求

• 負責品質系統文件、SOP、法規文件審核與批准

• 與研發、生產、法規事務部門協作，支持新產品上市

• Lead the quality department to ensure compliance with GMP and GDP standards

• Oversee product release, change control, deviation investigations, and CAPA activities

• Direct internal/external audits to ensure compliance across sites and supply chain

• Review and approve quality system documents, SOPs, and regulatory submissions

• Collaborate with R&D, manufacturing, and regulatory teams to support new launches