Asso. Director QA

6 days ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

My Client, a reputable global pharmaceutical company is looking out for a Associate Director, Asia QA to support their regional distribution Center.

**Job responsibilities**:

- Provide support to other Asia countries’ quality operations if needed.
- 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 to provide relevant QA input/support to selected business and Global QA projects, initiatives, and requests.
- Assume Quality Management Representative (QMR) Back-up role for Singapore and Malaysia sites to ensure continuous local QA operation (importation, local testing, repackaging, storage and distribution of company's products) as per applicable regulatory and company's requirements.
- Ensure continuous & compliance QA operations of company's Asia Regional Distribution Centre (RDC).
- Responsible for quality oversight of relevant Contract Manufacturing Operation (CMO) for Asia region to ensure the relevant CMO activities are compliant as per applicable regulatory and company's requirements. Also, to ensure company's products produced by the relevant CMO is compliant to applicable established and registered product specifications and requirements.
- Management/execution of external/internal audit program for Asia as per applicable local regulatory and global requirements.
- Responsible for Asia QA Quality Management System; develop, implement and maintain a fit for purpose regional QMS as per applicable regulatory and company's requirement in order to support Asia region and/or country quality operation/activities.

**Requirements/Skills**:

- Good knowledge and experience (3-5years) in working as regional commercial QA managerial role in Asia region.
- Good 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.
- More than 10 years’ experience in Pharmaceutical and/or Medical Device Company in quality function with 6-10 years in commercial Quality environment, 3-5 years in GMP Quality environment and 3-5 years in Quality supervisory role.
- Sound 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 managing supplier audits, internal audits, regulatory authority inspections.
- Experience on quality management or oversight of CMO is a plus.
- Ability to work independently and identify compliance risks and escalate when necessary
- Good sense of urgency and strong follow up
- Ability to travel within the region

**How to Apply**

Consultant: Tan Jun Jie
EA personnel reg. no.R1878852
EA License No. 17C8502

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