[Philippines] Quality Assurance Specialist

POSITION PURPOSE

The primary purpose of this QA Executive role is to ensure that all Santen products and related operations in the Philippines consistently meet stringent quality and regulatory standards. This involves establishing maintaining and overseeing a robust Quality Management System (QMS) that complies with both local Philippine regulations and Santens global quality requirements. The role is critical for ensuring the continuous supply of high-quality compliant products to the market.

PRINCIPAL ACCOUNTABILITIES

• Perform quality operations for Santen in Philippines to ensure its compliance with applicable local regulatory authority and Santens global requirements for importation local testing repackaging release storage and distribution of Santen products.
• Develop implement and maintain of a systematic effective and efficient local Quality Management System (QMS) as per applicable local regulatory authority and Santens global requirements.
• Perform/support quality activities and resolve quality issues for Santen in responsible country to support the continuous supply of Santen products in these countries in compliance to applicable local regulatory authority and Santens global/release requirements.
• Provide support to develop implement and maintain a fit for purpose local QMS as per applicable requirements to support country quality operation/activities in responsible country.
• Oversee quality related matters and work together with 3PL in responsible country to ensure operations at 3PL are in compliance with applicable local law/regulation and Santens requirements and Santens requirements.
• Prepare and/or provide support to the management of all relevant regulatory inspections or certification audits for responsible country (GDP/GDPMD by regulators or certification body) to ensure successful maintenance / renewal of license and certification.
• Prepare and/or provide support to the management of external/internal audit program for Santen in responsible country as per applicable local regulatory and Santen global requirements.
• Ensure all relevant Quality support are provided for all relevant post market activities for Santen in responsible country and are executed timely as per local regulatory authority and Santens global requirements so as to minimize product supply interruption (e.g. support relevant document and communication preparation for local regulatory authority on product testing market action field correction actions and recall).
• Provide support to all relevant quality input/support to business projects new product introduction product launches and product variation in responsible country are provided timely.
• Provide support to the management of chemical reagents and reference standard to ensure its continuous supply for local product testing if required.
• Represent Asia QA team to provide relevant QA input/support to selected business projects/initiatives if required.
• Provide support to other Asia countries quality operations if required.

Qualifications :

Education and Experience Requirements

• Successful completion of relevant tertiary qualification Science Degree.
• 3-5 years experience in Pharmaceutical and/or Medical Device Company in quality function with 1-2 years in GMP manufacturing plant environment or warehouse/distributor environment with 2-3 years in commercial Quality environment.   
• Proven knowledge and experience on the development implementation and maintenance of a Quality Management System as per Taiwan regulatory requirements on Good Distribution Practice (GDP) or Good Distribution Practice for Medical Device (GDPMD) and NMC corporate standards is preferred.
• Some knowledge and experience working with regulators and local distributors on local product testing issues resolution and management. Some knowledge of local regulatory requirement on local product secondary packaging and local product testing.
• Some 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.
• Proven 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
• 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 with a great degree of autonomy as part of 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 and as applicable local language is desired

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

Leadership Behaviors

• • Be Positive
  • Be Accountable
  • Be Results Oriented
  • Be an Excellent Manager of Self

Complexity and Problem Solving skills

• Strive to drives the business forward and look for practical and compliant solutions to issues.
• Understands total potential impact and contributes significantly to the solution of simple or complex issues arising
• Expected to work with a number of suppliers / products
• Provide a positive and solution oriented environment
• Uses experience to facilitate troubleshooting and to tackle non-routine work and projects independently
• Offers constructive comments and proposes improvements and rationalizations to systems policies and procedures
• Uses own judgment to assess what to refer upwards and what to deal independently

• Internal and External Contacts

• Primary Internal Contacts:
  • Country Management(s)
  • Santen Plant Quality functions
  • Global Quality teams
  • Supply Chain
  • Regulatory Affairs
  • Safety Vigilance
• Primary External Contacts:
  • Suppliers
  • Transporter
  • Distributor partners
  • CMO
  • Customers

• Other Job Requirements

  Travel required for meetings provide quality support and/or auditing suppliers. Travel to responsible countries is required for operation activities and for inspections.

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 - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes education and treatment. At Santen we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs role requirements and individual qualifications regardless of race color ethnicity national origin/ancestry religion sexual orientation gender gender identity/ expression age disability medical condition marital status veteran status or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process please let the recruiter from our team know.

Remote Work :

No

Employment Type :

Full-time