Senior Manager, Supply Chain and QA, APAC

Republic of Korea, Seoul · Full-time

About The Position

Medison stands as a distinctive global pharmaceutical company, driven by an unwavering purpose: to deliver groundbreaking therapies to patients suffering from rare and severe diseases across international markets. We believe that all patients, wherever they are in the world, have the right to get access to the best available novel treatments, and we are here to make this happen. As we continue our global expansion, we seek individuals who share our passion and principles, are eager to build and make a difference.

We are patient-centric, innovative, agile, and always ahead.


Responsibilities

Supply Chain

  • Responsible for all the logistics for Medison APAC ex ANZ inclusive of 3PL (inbound, customs clearance, storage, transportation, order-to-cash) and trade relations
  • Lead the development of the product supply plans and manage local inventory levels to pre-defined targets. Lead Sales & Operations planning process with internal and external partners.
  • Responsible for contract management with respective suppliers
  • Responsible for 3rd party warehouse operations and ensuring that supplier performs as per outlines KPI’s
  • Local Subject Matter Expert for NetSuite.
  • Good knowledge and experience in working with cross functional teams across APAC.
  • Support Global Finance on all partner reporting requirements.
  • Operations budget(s) review and forecasting
  • Leadership capabilities. being able to work with and guide a multi-functional team in a global environment.

QA

  • Participate in designing, implementing, maintaining, and improving quality system
  • Ensure the QMS is compliant to regulatory requirements, including but not restricted to GMP and GDP requirements.
  • Independently initiate and approve SOP updates and creation of new SOPs.
  • Additionally oversee review of SOPs and associated documentation to ensure review requirements are met
  • Provide hands on quality expertise to colleagues and partners to support their quality and business needs
  • Participate in vendor management program, vendor oversight, QTA generation and auditing including lead auditor role to evaluate partner/vendor’s QMS, resources, premises and equipment
  • Lead self-inspections of Medison GMP/GDP operations.
  • Lead Medison Management Review in APAC to assess the effectiveness of the QMS and to highlight continuous improvements as appropriate
  • Ensure change control requests, deviations, complaints and CAPAs are reviewed using risk-based principals to comply with applicable requirements Participate in regulatory inspections as required
  • Participate in recall and mock recall operations Carry out any other duties that maybe reasonably
  • To be the responsible import pharmacist and perform all the duties of that function as required by law, for Medison Korea if candidate is based out of South Korea.

Requirements

  • Bachelor’s degree or equivalent experience,
  • A registered pharmacist if the candidate is based in South Korea.
  • 7 -10 years of related pharmaceutical, biotech experience
  • Thorough knowledge of supply chain operations processes for the APAC innovative
  • pharmaceutical / biotech market
  • Experience managing and interfacing effectively with senior stakeholders.
  • Significant negotiation experience
  • Experience working with a multi-national company preferred.
  • Thorough knowledge and understanding of Pharmaceutical Quality System
  • requirements, including Good Distribution Practices and Good Manufacturing
  • Practices.
  • Have experience in Quality function
  • Root cause analysis and investigation skills
  • Technical report writing
  • Have experience in auditing and quality systems
  • Experience in regulatory inspections is desirable
  • Strength in critical thinking, problem solving, and decision making
  • Collaborative nature, self-directed and independent
  • Strong business acumen
  • Cross-functional leadership
  • Executive level communication and presentation skills
  • Patient first mentality
  • Leads with Integrity and Respect
  • Delivers Results
  • Embodies the Medison DNA