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[asia] Regional Head, Quality Assurance
3 weeks ago
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.
The Asia Head of QA is responsible to lead the planning, preparation of strategy, maintenance and execution for quality assurance activities to realize high quality and consistency of Santen’s products in Asian region (except China) both in the development & commercial stages and spearhead the monitoring of quality risks for quality assurance of products manufactured, marketed and distributed in the region in terms of good distribution practice (GDP), good manufacturing practices (GMP), and Quality Management System(QMS) to support Santen’s strategic and business goals as well as continuous supply of quality compliant products.
**Job Description**:
- As a key partner to the business, the Head of Quality Assurance Asia is responsible for setting the appropriate standards and programs of quality for the products that will be delivered to patients in Asia
- Manages and leads the quality assurance (QA) units in Asian region except China. Especially ensures compliance with GDP and GMP in the region
- Establishes and manages the regional QA organization, including the annual management review, QA personnel and prioritizing group tasks, performing training, writing performance reviews and so on
- Oversees local QA activities in each country and regularly reports status to global headquarters, e.g., the maintenance and renewals of QA related Licenses for the local business, the local inspection to Santen by the competent authority, internal/external audits, the implementation of regional/local SOP, the documentation such as the product release and so on
- Manages the product complaints, products recall, the decision of product disposition, product release decision, change management and subcontract management in accordance with the SOPs and so on. Oversight the contract/agreement between local QA units and third parties is the critical responsibility for this position
- Leads and/or coordinates the internal/external compliance audits as required. Ensures audits are conducted on a continuing basis to ensure quality of outsourced GMP/GDP service agreement
- Develops and maintains Quality Management System (QMS) for Medical Device
- Leads and manages Medical Device Quality in the region according to medical device regulations. Such as ISO13485, local regulation and so on
- Support resolution of quality or compliance issues that require an in-depth knowledge of operational and regulatory requirements for Medical devices and Medical drugs
- Inform and escalate the leadership of global Santen about the quality or the compliance issues that could have a major impact to the quality integrity, the global business and so on
- Supports the good interface and good relation of the country RA contact with regulatory agencies as required
- Provides the business development with appropriate quality information in the timely fashion
- Ensures quality inputs and support are provided timely to the relevant business projects in the responsible region
**Qualifications**:
- A graduate degree in the college or a relevant life sciences discipline.
- A pharmacist license is plus
- More than 10 years of hands-on experience in a regulated pharmaceutical industry setting, specifically including Quality Assurance, Supply Chain Management and/or Drug Regulatory Affairs
- Minimum 3 years of prior experience with drug substances and drug product releases, stability programs, sample testing, software validation, exception reporting and investigations under GDP and GMP.
**_ Other Requirements:_**
- Excellent knowledge of regulation relating to Quality Assurance
- Solid understanding of pharmaceutical manufacturing and/or laboratory work (including familiarity with various analytical techniques)
- Solid decision-making skills, inter-dependent partnering skills, team-orientation and demonstrated ability to influence outcomes.
- Well-organized and detail oriented, with strong verbal and written communication skills in English
- Ability to effectively participate in multi-disciplinary teams, strong hands-on leadership and management skills
- Hands on experience in implementing quality systems in a GDP / GMP environment and knowledge about Asian regulations, industry practices and requirements
- Solid computer skills, using ERP such as SAP, Trackwise and so on.
- Knowledge of products development process, eye diseases, and ophthalmic products is plus.
Additional Information
**Grow your career at Santen**
A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressin
