Regional QA Manager, Asia QA

Company Description*
Santen *is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.
- Manage/perform quality operations for Santen in responsible countries in Asia region (Singapore, Malaysia, Indonesia, Brunei, Australia) to ensure its compliance with applicable local regulatory authority and Santen’s global requirements for importation, local testing, repackaging, storage and distribution of Santen products.
- Perform Quality Management Representative (QMR) Role for Santen in responsible countries and ensure the development, implementation and maintenance of a systematic, effective and efficient local Quality Management System (QMS) as per applicable local regulatory authority and Santen’s global requirements.
- Perform QMR Role for Santen in responsible countries to ensure the local QA operation/activities are performed as per local as per applicable local regulatory authority and Santen’s global requirements.
- Provide support for the development, implementation and maintenance of a fit for purpose regional QMS as per applicable to support Santen Asia region and/or country quality operation/activities. Be the Lead for activities in this part if needed.
- Provide support for quality oversight of relevant Contract Manufacturing Operation (CMO) and/or Supplier in Asia region to ensure the relevant CMO/Supplier activities are compliant as per applicable regulatory and Santen global requirements. Provide support to ensure Santen products produced by the relevant CMO is compliant to applicable established and registered product specifications and requirements.
- Manage all relevant regulatory inspections or certification audits for SG and MY (GDP/GDPMD by regulators or certification body) to ensure successful maintenance / renewal of license and certification.
- Provide support to manage the planning and execution of external/internal audit program for Santen Asia as per applicable local regulatory and Santen global requirements.
- Perform quality activities and resolve quality issues for Santen in responsible countries and/or region to support the continuous supply of Santen products in these countries in compliance to applicable local regulatory authority and Santen’s global/release requirements.
- Provide support to ensure all relevant quality input/support are provided for all relevant post market activities for Santen in responsible countries are executed timely as per applicable local regulatory authority and Santen’s global requirements so as to minimize interruption to supply of quality compliant product.
- Provide support for the management of chemical reagents and reference standard to ensure its continuous supply for local product testing (as required).
- Provide support to ensure all relevant quality input/support to business projects, new product introduction, product launches and product variation in responsible countries are provided timely.
- Represent Asia QA team as Asia QA Lead to provide relevant QA input/support to selected business projects/initiatives.
- Provide support to other Asia countries’ quality operations if needed.

**Qualifications**:

- 7 -10 years’ experience in Pharmaceutical and/or Medical Device Company in quality function with 3-5 years in GMP manufacturing plant environment with 3-6 years in commercial Quality environment.
- Knowledge and experience in working as Quality Management Representative on the development, implementation and maintenance of a Quality Management System compliant to Asia regulatory requirements on Good Storage Practice (GSP) and Good Distribution Practice (GDP), Good Distribution Practice for Medical Device (GDPMD) and NMC corporate standards is preferred.
- Direct knowledge and experience working with regulators and local distributors on local product testing issues resolution and management. Good knowledge of local regulatory requirement on local product secondary packaging and local product testing.
- Proven experience on relationship management and networking with regulators and local distributors.
- Good knowledge and experience on performing quality operation activities and the regulatory requirements for the importation, repackaging, release, storage and distribution of pharmaceutical and medical devices products (including sterile, liquid/solid products and cold chain) is preferred.
- Direct knowledge and experience in working with cGMP and quality management system elements and guidelines (e.g. PIC/s, ICH, ISO9001 or ISO 13485) and cold chain product repackaging
- Experience in supporting supplier audits, internal audits, regulatory authority inspections
- Experience on quality monitoring or management of CMO is a plus.

Additional In