[KOREA] QAQC Assistant Manager

•  Assume Deputy role for Import Manager as needed.
• Manage/ perform quality operation/activities for Santen Korea to ensure its compliance with applicable local regulatory and Santen requirements for importation local testing repackaging release storage and distribution of Santen products.
• Provide Quality leadership and author support documentation for individual markets release supporting documents for individual market release supporting documents to meet local regulatory requirements.
• Provide support to maintain a fit for purpose local QMS as per applicable local regulatory authority and Santens global requirements to support country quality operation/activities.
• Responsible for quality oversight of relevant local Contract Manufacturing Operation (CMO)/Supplier/Distributor to ensure the relevant CMO/Supplier/Distributor activities are compliant as per applicable regulatory and Santen global requirements. Provide support to ensure Santen products produced by the relevant CMO is compliant to applicable established and registered product specifications and requirements. Support new product launches and technology transfers as needed.
• Partner with colleagues to develop and negotiate quality agreements.
• Provide Quality Leadership for change management and significant deviations at CMO/supplier/distributor sites that may impact compliance status or require regulatory notifications.
• Lead quality risk management activities and manage mitigation plans within CMO/supplier/distributor.
• Perform quality activities and manage quality issues for Santen Korea/ CMO to support the continuous supply of Santen products in compliance to applicable local regulatory authority and Santens global/release requirements.
• Quality activities include performing maintenance of quality agreement change control KPI monitoring quality complaints management PMF update SOP updates and periodic review of QA SOPs training self-inspection and audits deviation/CAPA risk assessment preparing Annual Product Quality Review etc.
• Responsible for management of the contracted laboratories and ensure that method transfers are completed and compliant to applicable established and registered product specifications and requirements.
• Provide support for the management of chemical reagents HPLC columns and reference standards to ensure its continuous supply for local imported product testing.
• Provide support to ensure all relevant quality input/support to business projects new product introduction product launches (including Analytical Method Transfer) and product variation are provided timely.
• Support all relevant regulatory inspections or certification audits for Santen Korea to ensure successful maintenance / renewal of license and certification.
• Support management and execution of external/internal audit program for Santen Korea as per applicable local regulatory and Santen global requirements.
• Provide support to ensure all relevant quality input/support are provided for all relevant post market activities for Santen Korea on time as per applicable local regulatory authority and Santens global requirements so as to minimize interruption to supply of quality compliant product.
• Represent Santen Korea to provide relevant QA input/support to selected business projects/initiatives.
• Participate in ad-hoc activities as requested.

Qualifications :

Education and Experience Requirements

• Successful completion of relevant tertiary qualification pharmacy degree. Licensed Pharmacist.
• At least 8 QA/QC experience in Pharmaceutical and/or Medical Device Company in quality function preferably with 5 years in GMP manufacturing plant environment and/or with 3-5 years in Commercial Quality environment.
• Management skills for leading projects and delivery of on-time activities.
• Knowledge and experience in development implementation and maintenance of a Quality Management System compliant to local regulatory requirements on Good Manufacturing Practice (GMP) / Good Storage Practice (GSP)/Good Import Practice (GIP)/ Good Distribution Practice (GDP) and MMC corporate standards is preferred.
• Good experience on quality monitoring and management of CMO/Distributor/contract laboratory.
• Good knowledge and experience working with regulators
• Good knowledge of local regulatory requirement on local product secondary repackaging and local product testing.
• Good knowledge and experience on performing quality operation activities and understanding the regulatory requirements for the importation repackaging release storage and distribution of pharmaceutical and medical devices products is preferred.
• Direct 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 supporting supplier audits internal audits regulatory authority inspections.
• 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 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 Korean and English.

Leadership Behaviors

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

Complexity and Problem Solving skills

• Strive to drive 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 Contact : Country Management(s) Santen Plant Quality functions Global / Regional Quality teams Supply Chain Regulatory Affairs Safety Vigilance Primary External Contacts Suppliers Contract laboratories Distributor partners/ Third Party Logistics (3PL) Contract Manufacturer
• Other Job Requirements: Hybrid work arrangement.
• Working 2-3 times a week at 3PL may be needed to perform importation work tasks.
• Travel required for meetings provide quality support and/or auditing suppliers.
• Travel to responsible countries is required for operational activities and for inspections.

Additional Information :

Please submit the resume in Resume Format template.

Submit in 2 languages please. (Korean & English)

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.

*Please note that team assignments may be subject to future changes