Remote Quality Lead – GDP, Regulatory & PIC Liaison

Takeda Pharmaceutical Co.; Hong Kong; Remote; HKD 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

Takeda Pharmaceutical Co. in Hong Kong seeks a senior quality leader to oversee GDP compliance as the designated Responsible Person for the Wholesale Dealer Licence, ensuring compliant handling, storage, distribution and supply of pharmaceutical products.

You will partner with regional and global quality teams and cross-functional partners, drive continuous improvement, inspection readiness and regulatory interactions with the Hong Kong HA.

Qualifikationen

• Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Quality Management, or related discipline.
• Minimum 10 years of solid experience in pharmaceutical distribution, quality assurance, GDP/GMP compliance.
• Eligible for appointment as PIC under HK Wholesale Dealer Licence framework.
• Strong knowledge of HK GDP requirements and relevant pharmaceutical legislation.
• Competence in quality management systems, risk management, deviation/CAPA management, supplier qualification and product recalls.
• Experience in supporting regulatory inspections and interactions with Health Authorities.
• Fluent in English, Mandarin and Cantonese.

Aufgaben

• Lead Hong Kong and Macau Commercial Quality activities in partnership with Regional CQ Leaders and serve as the strategic quality partner to Commercial, Supply Chain, Regulatory Affairs, Pharmacovigilance, and Medical.
• Implement and maintain local Quality Management System (QMS) processes in compliance with applicable GDP requirements, local regulations, and Takeda standards; oversee distribution and storage controls, quality surveillance, product returns, batch disposition, deviations, CAPAs, and change management.
• Provide quality support and oversight for new product launch readiness and, where applicable, local contract manufacturing, packaging, analytical testing, GCP, GVP, medical device, Medical, PAP, and PSP activities.
• Take part in self-inspections, compliance monitoring, and quality risk management, and drive continuous improvement through process simplification, standardization, and digitalization.
• Maintain inspection readiness, host Health Authority inspections, manage regulatory communications for quality and compliance related matters, and lead the escalation and resolution of market-level product quality and compliance issues.
• Serve as the Hong Kong Person in Charge (PIC) for Wholesale Dealer Licence (WDL) activities, including: act as the designated PIC of poisons and/or pharmaceutical products for Takeda Hong Kong WDL activities and ensure compliance with regulatory requirements; oversee distribution activities; approve returned product handling; ensure storage controls; review WDL procedures, investigations, CAPAs, risk assessments, complaints, recalls; ensure records are complete; lead regulatory inspections and HA communications; drive remediation of quality and business risks; ensure GDP training.

Kenntnisse

Stakeholder management

Communication

Influencing skills

English (fluent)

Mandarin (fluent)

Cantonese (fluent)

Ausbildung

Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Quality Management, or related discipline

Jobbeschreibung

Takeda Pharmaceutical Co. in Hong Kong seeks a senior quality leader to oversee GDP compliance as the designated Responsible Person for the Wholesale Dealer Licence, ensuring compliant handling, storage, distribution and supply of pharmaceutical products.

You will partner with regional and global quality teams and cross-functional partners, drive continuous improvement, inspection readiness and regulatory interactions with the Hong Kong HA.