Director Quality Assurance ( Healthcare)

DKSH (Thailand) (Bangkok, Bangkok City, Thailand)

Bangkok, Thailand

About DKSH DKSH’s purpose is to enrich people’s lives by providing access to goods, services, and insights. United by our vision to be the trusted partner, we help companies grow in Asia and beyond across our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology. Delivering life-saving drugs to hospitals, bringing high-quality products to remote villages, installing technology that raises living standards, and providing new formulations for healthcare products that make life easier. These are just a few examples of how DKSH touches people’s lives around the clock. We do this while helping our clients and customers grow by providing services including marketing and sales, distribution and logistics. Headquartered in Switzerland, DKSH is publicly listed and operates in 37 markets across Asia Pacific, Europe, and North America. We have over 32,000 specialists and generated net sales of CHF 11.3 billion in 2022.

About this position

Leads Quality Assurance functions with sound judgment and strategic planning to ensure full compliance with statutory authority requirements and at the same time, supporting DKSH internal teams in achieving organizational success.

Responsibilities

• Operates to maintain a state of quality oversight control and keep the QMS current with good industry practices.
• Ensuring DKSH Healthcare operations are in compliance with applicable government laws and regulations, GDP & GMP requirements.
• Maintenance of the various licenses required to operate DKSH Healthcare’s Distribution Centre.
• Report QMS metrics (ie KPIs), including trends that helps decision-making and taking proactive corrective/preventive actions.
• Review complaints/incidents/deviations to determine if it relates to a failure to meet specification/procedure/regulatory requirement, if so investigate and report to top management, client and/or health authority if it is critical / serious / life threatening.
• Identify, develop and establish contact with new/potential/existing business partners in line with Company business development strategy and prioritizing business opportunities. Manage profit and loss of QA teams by planning resources versus income.
• Leads the QA teams to ensure roles and responsibilities are carried out diligently, meeting clients contracted Quality Agreements.
• Ensuring continuous improvement in processes are in place in order to optimize warehousing and distribution activities.
• Provide QA training to internal teams to ensure strong foundation for compliance to regulatory requirements thus contributing to organizational success.
• Provide QA training externally to business partners, whenever required.
• Coordinate and lead all Healthcare related audits (Internal & External).
• Organize reviews with key Clients Quality Management (together with DKSH Supply Chain Management).
• Organize reviews Certification projects.
• Attend quality audit which are conducted by key Regional Clients (Roche, BMS, Novo…) when required.
• Report to VP Business Unit HEC after summary investigation when critical events happen to ensure senior management is made aware of such events.
• Review Corrective and Preventive Actions for critical Audit Reports.
• Coordinate specific projects such as Cold Chain management, Transportation Management and lay-out of new DC’s.

Requirements

• Quality experiences for a pharmaceutical distribution organization and working knowledge on the requirement from the Ministry of Health (MOH) for distribution of regulated drugs.
• Working knowledge of ISO 9001, ISO 13485, GDP and GDPMD in addition to being qualified as the Lead Auditor.
• Degree in Pharmacy / Thailand Registered Pharmacist or Degree in Science.