Position Summary:

Responsible for the commercial QA activities within Singapore, Vietnam & Malaysia for Teva products, including but not limiting to Branded/Specialty, Generics, Branded Generics and Biosimilars.

Specific Responsibilities:

• Responsible for quality oversight and regulatory compliance of products marketed in the country.
• Responsible for quality approval and management of local 3rd party suppliers/manufacturers/distributors
• Roll out of Teva Quality Management System
• Attend to quarterly quality councils
• Provide monthly quality metrics
• Operational implementation of Quality Management system

Market release

• Ensure the market release from approved suppliers based on batch release documentation and transport conditions documentation.
• Ensure the distribution traceability of finished products and returns of products commercialized in the country.

Distribution

• Ensure the GDP compliance of the distribution centers.

Complaints and Recalls

• Ensure that quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions. Where necessary, liaise with pharmacovigilance department.
• In case of recall ensure the local and regional coordination between PhV, medical affairs, regulatory affairs, supply chain, etc. and with EU Qualified person concerned. Escalate any critical information to (sub regional) head of commercial quality and issue the final recall report.

Change control, deviations and CAPAs

• Administer, maintain and develop systems for change control, and deviation and CAPA handling

Distributors, Suppliers/Manufacturers and 3rd party service providers

• Maintain, monitor and approve a list of approved 3rd parties

Archiving

• Ensure that relevant quality related documentation is archived as required

Report critical quality incidents to Management

• Report to Regional/Corporate Quality and local management on any critical quality incident

Internal and External Relations

• Set up and maintain contacts with key stakeholders, including General Manager, RA, drug safety officer, medical manager, launch manager, Quality personnel at the Teva and 3rd party manufacturing/batch release sites, distributors and other relevant companies.

Qualifications & Experience:

• Degree in Pharmaceutical Sciences, Business, Healthcare or an equivalent combination of education and experience to the functional role. Advanced degree is an advantage.
• Minimum of 2 - 4 years experience as a Quality Manager/QP in a pharmaceutical company or importer/distributor.
• Demonstrated knowledge and working experience with PIC/S GMP and GDP and government regulations for the country
• In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance
• Working knowledge of pharmaceutical import and distribution operations
• Commercial understanding of corporate and operational business issues
• Fluent in written and spoken English
• Ability to clearly communicate with all levels in the organization as well as with Health Authorities
• Excellent interpersonal skills to interface directly with management, sites, commercial and distributors
• Strong analytical, planning and strategic thinking skills
• A self-starter and have a hands-on approach and a strong "can do" attitude. Ability to work independently, be self-motivated, result oriented.
• Openness to change and ability to think out of the box
• Global mindset and experience working in a global, multi-national pharmaceutical company
• Proficient computer skills including MS Office
• Teamwork/collaboration