Description
A high-visibility QA leadership role for a licensed South Korean Pharmacist to drive, manage, and continuously optimize the local Quality Management System (QMS). Serving as the primary site subject matter expert, you will possess independent oversight of all compliance frameworks, strategic audits, and regulatory relationships.
Essential Functions
·Strategic QMS Management: Establish and optimize the localized QMS to ensure absolute alignment with both global quality strategies and South Korean regulatory expectations.
·Audit & Regulatory Management: Act as the primary interface and host for all regulatory inspections (including MFDS and KGSP) as well as global healthcare and clinical trial (IMP) client audits.
·CAPA & Root-Cause Ownership: Oversee complex investigations, deviations, Corrective and Preventive Actions (CAPA), and robust local change control operations.
· Cold-Chain & Specialized GxP Oversight: Deliver rigorous technical quality oversight for cold-chain logistics, investigational medicinal products (IMPs), and medical device inventory. (GDP ,KGSP, GMP as applicable)
·Mentorship & Quality Culture: Coach, train, and guide junior quality staff and cross-functional operations colleagues to build a proactive culture of regulatory readiness.
·Operational Monitoring: Perform routine checks on inbound/outbound shipment, facility temperature logs, environment parameters, and warehouse GxP compliance. (GDP ,KGSP, GMP as applicable)
1. Quality Assessment & Standards: Transportation & Fulfilment SOP & Work Instruction Development; FedEx Network and Facilities (Hubs, Stations) Policies & Procedures Development & Implementation; Quality & Regulatory Advisory
2. Quality Management: Quality Corrective & Preventive Actions; Quality & Compliance Advisory; Quality & Compliance Performance; Compliance & Quality Program Implementation; Continuous Improvement of QMS & Processes; QMS Implementation & Administration
3. Quality Audit: Internal Audit Process Design & Implementation Support; Certification Aud
it Support; Customer Audit Programs Support; Audit Strategy & Readiness Program Documentation; Audit Program
4. Healthcare Customer Liaison: Customer Request / Issue Resolution; Quality Agreements, Questionnaires & RFQ Proposal
Education: Bachelor's degree or equivalent in Science, Pharmacy or related discipline.
Experience: Five (5) years relevant experience in pharmaceutical or healthcare industry in a quality compliance related role
Pharmacist License holder preferred.
FedEx was built on a philosophy that puts people first, one we take seriously. We are an equal opportunity/affirmative action employer and we are committed to a diverse, equitable, and inclusive workforce in which we enforce fair treatment, and provide growth opportunities for everyone.
All qualified applicants will receive consideration for employment regardless of age, race, color, national origin, genetics, religion, gender, marital status, pregnancy (including childbirth or a related medical condition), physical or mental disability, or any other characteristic protected by applicable laws, regulations, and ordinances.
Our Company
FedEx is one of the world's largest express transportation companies and has consistently been selected as one of the top 10 World's Most Admired Companies by "Fortune" magazine. Every day FedEx delivers for its customers with transportation and business solutions, serving more than 220 countries and territories around the globe. We can serve this global network due to our outstanding team of FedEx team members, who are tasked with making every FedEx experience outstanding.
Our Philosophy
The People-Service-Profit philosophy (P-S-P) describes the principles that govern every FedEx decision, policy, or activity. FedEx takes care of our people; they, in turn, deliver the impeccable service demanded by our customers, who reward us with the profitability necessary to secure our future. The essential element in making the People-Service-Profit philosophy such a positive force for the company is where we close the circle, and return these profits back into the business, and invest back in our people. Our success in the industry is attributed to our people. Through our P-S-P philosophy, we have a work environment that encourages team members to be innovative in delivering the highest possible quality of service to our customers. We care for their well-being, and value their contributions to the company.
Our Culture
Our culture is important for many reasons, and we intentionally bring it to life through our behaviors, actions, and activities in every part of the world. The FedEx culture and values have been a cornerstone of our success and growth since we began in the early 1970's. While other companies can copy our systems, infrastructure, and processes, our culture makes us unique and is often a differentiating factor as we compete and grow in today's global marketplace.