[Vietnam] Senior Quality Assurance Executive (Binh Duong)

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.

POSITION PURPOSE

As a Senior QA Executive at Santen Pharma Vietnam, you'll be crucial in upholding the highest quality standards across all operations. You'll ensure full compliance with local regulations and Santen's global policies for importing, testing, repackaging, storing, and distributing our products.

You'll also support the QA Manager in developing and maintaining a robust Quality Management System (QMS) and lead the planning and execution of internal and external audits. A key part of your role will be proactively resolving quality issues to ensure a continuous supply of compliant products and providing essential quality input for post-market activities, new product introductions, and business projects.

Additionally, you'll support the management of chemical reagents and reference standards for product testing, assist with regulatory inspections, and act as a backup for the Designated Competent Person role in Vietnam. There may also be opportunities to support quality operations in other Asian countries.

PRINCIPAL ACCOUNTABILITIES

• Ensure all local quality activities related to the importation, local testing, repackaging, release, storage and distribution of Santen products are performed timely and according to applicable local regulatory and Santen’s global requirements.
• Manage quality complaint, perform/ support quality activities and resolve quality issues to support the continuous supply of Santen products in compliance to applicable local regulatory and Santen’s global/regional requirements.
• Perform Back-up Designated Competent Person role for Santen Vietnam and ensure the implementation, and maintenance of a systematic, effective, and efficient local Quality Management System (QMS) as per applicable local regulatory and Santen’s requirements.
• Support development, implementation, and maintenance of local QMS as per applicable requirements to ensure compliant local quality operation operations/activities.
• Ensure SOPs/WIs, QMS management principles are adhered to, review impact assessments and implement any update to QMS policies.
• Manage external/internal audit program for Santen as per applicable local regulatory and Santen global requirements. Conduct inspection for GSP WH, lead and coordinate to related functions to complete the investigation of findings and monitor all CAPAs.
• Plan and perform the audit to wholesaler(s) and GxP vendors, evaluate the root cause and CAPA plan from the auditees and follow up the CAPA status after the audit.
• Monitor CAPAs of GxP from complaint, deviation, incidents, audit, etc… to ensure the proper completion and documented evidence.
• Monitor Change control process, complete risk assessment which is aligned with QA Manager. Ensure all change approved and implemented properly with the change owners.
• Support all relevant post market activities, ensure them being executed timely as per local regulatory and Santen’s global requirements so as to minimize any product supply interruption (e.g. support relevant document and communication preparation for local regulatory authority on product testing, market, field correction actions and recall).
• Management of chemical reagents and reference standard to ensure its continuous supply for local product testing (if needed).
• Support to ensure all KPIs for local quality operation meet the established requirements.
• Support management of all relevant regulatory inspections or certification audits for responsible countries (e.g. GSP by regulators or certification body) to ensure successful maintenance / renewal of license and certification.
• 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.
• Proactively handle tasks and make recommendations, while ensuring alignment with the QA Manager before final decisions are made.
• Provide support to other Asia countries’ quality operations if needed.

Education and Experience Requirements

• University degree in Pharmacy.
• Have the pharmacy practice certificate with scope of importation of drugs.
• Minimum 3 years’ experience in Pharmaceutical and/or Medical Device Company in quality function.
• Good knowledge and experience in working as Designated Competent Person on development, implementation, maintenance of a QMS compliant to DAV GSP requirements for local affiliate and GSP warehouse for pharmaceutical, medical device, food supplement products importation, storage is preferred.
• Good experience and knowledge in working as Quality Representative on the development, implementation and maintenance of a QMS compliant as per Good Distribution Practice (GDP), Good Distribution Practice for Medical Device (GDPMD) and NMC corporate standards is preferred.
• Good knowledge of local regulatory requirement on local product secondary packaging and local product testing.
• Good experience on relationship management and networking with regulators and local distributors.
• Good knowledge and experience on managing/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.
• Experience in managing supplier audits, internal audits, regulatory authority inspections is preferred.
• Ability to work independently and identify compliance risks and escalate when necessary
• Good sense of urgency and strong follow up.
• Scientific Knowledge.
• Ability to manage complex projects and timelines in a matrix team environment.
• Demonstrated interpersonal skills including strong negotiation skills.
• Excellent teamwork and coordination skills

Key Skills, Abilities, and Competencies

• Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team.
• Execute goals and objectives in a driven and a high-performance culture, and as applicable with ability to achieve results with non-direct reports.
• Organization agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence of stakeholders.
• Able to work independently and take initiative, with regular updates and alignment with the Line Manager.
• Able to work with a great degree of autonomy, as part of a global virtual team.
• Able to work cross-functionally and cross-culturally, in a global business environment.
• Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed.
• Able to adapt to changes and positively respond to changes.
• Enthusiastic, resilient, dynamic, versatile. Display 'Can do' attitude.
• Good interpersonal and communication skills.
• Excellent verbal and writing skills and fluent in English

Living our leadership behaviors is a basic expectation for all Santen employees. Santen expects all employees to embody the following:

• Complexity and Problem Solving skills
• Strive to drives the business forward and look for practical and compliant solutions to issues.