Regional Quality Assurance Director, APAC | Pharma MNC

Job description

Job Summary:

• Overseeing and supporting the APAC affiliates in all matters related to a QMS, Quality and Technical aspects of manufacture, new product development/ introduction, managing quality needs in product release, good storage, distribution and supporting compliance efforts related to GxP regulatory requirements.

Responsibilities

• Management
  • Responsible for ensuring a solid QMS framework to support affiliates in efficient GxP quality management and providing Quality / Technical support for the Region’s 3rd party manufacturing plants and distribution centers for manufacture, importation, receipts/release, storage, distribution in order to comply with Health Authority regulations and MAH requirements.
  • To ensure these are operating under the company acceptable Quality and Regulatory standards and within a QMS framework.
• Technical Review for Business Alliance
  • Support Business Development efforts in forging new business alliances by performing the necessary due diligence based on quality and technical evaluations with the express purpose of identifying potential issues and risks and to quantify these in terms of financial value/investment required
• Review Quality Agreements of intra company stakeholders, suppliers, manufactures and business Partners
• Develop, archive and maintain company’s product intellectual assets through product monograph development and support documents to facilitate internal technical transfers or in case of selling of product assets in future
• Plan Budgeting
• Conduct internal and external audits of the affiliate manufacturing plants including 3rd party manufacturing and support functions:
  • Verify adherence to policy, procedures, current accredited GMP (PICs, USFDA or WHO) or ISO procedures, depending on the category of products.
• Ensure staff are trained to reliably and accurately perform their work to the necessary Quality standards.
• Takes an active role in professional activities such as Asean regulatory harmonization, which dictates Regulatory and Quality standards for the region.

Experience

• Experience and qualification - Honors or higher degree in related pharmaceutical Science is essential;
• Five or more years in a Regional Quality / Technical management function in a pharmaceutical company with exposure to international regulatory and QA requirements.
• Experience in all aspects QA/QC/Technical services function and understanding of pharmaceutical, medical device, cosmetic and supplement production processes, process validation, facilities and equipment qualification.
• Familiar with tools and methodologies of quality performance and achievement measurements to determine progress to advice management.
• Undertakes other tasks and responsibilities as may be defined by Regional requirements

Please contact Ewen Poh at +65 6950 0365 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.