Job Description

Head of Quality Assurance

• Head Quality Function for Myanmar, Thailand, Malaysia, Singapore, Indonesia, Brunei, Laos, Cambodia, Vietnam, Philippines, Hong Kong, Macau, Taiwan, South Korea, Australia & other markets.
• Serve as strategic lead and partner for Quality
• Serve as escalation point for Quality Matters
• Serve as stand-in Market Quality Leader (where necessary)
• Serve as Management Representative for Regional and where necessary in markets
• Serves a Quality Consulting Party for Business Unit Healthcare and Supporting Functions

General Responsibilities

• Maintain a state of quality oversight control and keep the QMS current with good industry practices.
• Ensuring DKSH Healthcare operations are following the applicable government quality regulations and related regulations, GDP & GMP requirements.
• Maintenance of the various licenses required to operate DKSH Healthcare’s Distribution Centre.
• Report QMS Metrics (i.e. KPIs) including trends that helps decision making and taking proactive corrective/preventive actions.
• Review complaints/incidents/deviations trends 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 and establish contact with 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.
• Lead the QA teams to ensure roles and responsibilities are carried out diligently, meeting international and market guidelines and client Quality Agreements in force.
• Acting as company liaison with Standards organizations and governmental agencies enforcing guidelines.
• Support markets in government agencies, accredited certification bodies, client and internal audit as required.
• Management Representative for Quality Management System (QMS) for Regional and support as Management Representative in markets where the appointed representative is unable to perform the required duties due to prevailing challenges.
• Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing redressing, productivity, quality and customer service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Develops quality assurance plans by conducting risk analyses; identifying critical control points and preventive measures; establishing quality KPI’s, monitoring procedures, corrective actions, and verification procedures.
• Update job knowledge by studying trends in and developments in quality management; participating in professional organizations.

Quality Management System (QMS)

• Describe how the organization follows GxPs and operated to maintain a state of quality oversight control.
• Keep the QMS current with good industry practice.
• Provide QA Training to internal team to ensure strong foundation for compliance to regulatory requirements thus contributing to organizational success.
• Ensuring continuous improvement in processes are in place in order to optimize warehousing and distribution activities.

Audit Compliance to Quality Management System (QMS)

• Assure timely self-inspections are conducted
• Support audits by governmental agencies, accredited certification bodies and clients to achieve favourable outcomes for the organization.
• Report QMS metrics (i.e. KPIs), including trends that help decision-making and taking proactive corrective/preventive actions.

Establish Procedures

• Ensure that procedures and policies are appropriate and followed.
• Ensure that documented procedures and records are current and compliant with international and market quality guidelines and quality regulations.
• Ensure the documented procedures and records cover all productive and quality processes.

Review, Approve or Reject Quality Related Actions

• Serve as the escalation point and final authority to review and decide upon all quality matters escalated to Regional.

Change and Non-conformance

• Ensure planned changes and detected non-conformances are adequately managed by markets to minimize risk to patient and to the organization.

• Review complaints/incidents/deviations trends 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.

Keep Management Informed

• Report on product, process and system risks-and keep management informed.
• Report on outcome of quality inspections and ensure responses are complete and managed to verifiable closure-and keep management informed.

Leadership responsibilities

• Provide strategic leadership across APAC for QA practices
• Champion quality for DKSH
• Foster a high-performing culture focused on accountability, learning, and speed-to-execution.
• Build capability across the QA teams in region by identifying gaps and investing in scalable skills.

Functional skills and knowledge

• Quality experiences for a pharmaceutical distribution organization and working knowledge on the requirement from the Ministry of Health (MOH) for distribution of regulated drugs, medical devices, health and traditional medicine, etc.
• Working knowledge of ISO 9001, ISO 13485 & GDP/GMD.
• Preferably Qualified Registered Pharmacist is preferred, but not mandatory.
• Qualified as the Lead Auditor (ie ISO 9001 or 13485) would be an added advantage.
• Demonstrate sound knowledge in quality assurance and controls
• Demonstrate sound knowledge of laws, regulations and international standards related to area of work (e.g. healthcare, etc.)
• Demonstrate basic CAPA & Root Cause analytical skills

Education & Work Experience

• Bachelor’s/ Master’s Degree in Quality Management, Pharmacy, Business, or Life Sciences or similar
• At least 10 years of quality assurance experience in a large multinational pharmaceutical organization or service provider.