Title:  Director, Quality Assurance (Healthcare)

Job Summary

Director, Quality Assurance for DKSH Healthcare 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.

General 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

Leadership Responsibilities

• Set direction and leadership for QA operations and take accountability for championing quality for DKSH
• Act as DKSH employee role model, taking account for own professional and technical development and excellence; and
• Lead, mentor and coach managers and team members
• Cultivate a culture of professionalism and high performance in line with DKSH corporate values

Requirements

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
• Working knowledge of ISO 9001, ISO 13485, GDP and GDPMD in addition to being qualified as the Lead Auditor

Soft skills

• Quality compliance focused and people focused approach towards management of quality issues, regulatory affairs and pharmacovigilance

Education

• Degree in Pharmacy

Work experience

• More than ten (10) years of quality assurance experience in a large pharmaceutical organization