General Electric Korea QA Leader - PDX in Seoul, South Korea
Job Description Summary
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
[Inclusion and Diversity]
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
[GE Healthcare 조영제 사업부]
GE Healthcare는 오랜 역사를 가진 풍부한 전문성과 Know-how를 바탕으로 조영제의 원료부터 완제품 생산까지 직접 제조 및 관리하고 있습니다. 전세계의 조영제 사용량이 지속적으로 증가함에 따라 조영제를 이용한 검사가 원활히 이루어질 수 있도록 GE Healthcare는 조영제 생산 및 공급에 대한 지속적이 인프라 투자를 통해 안정적인 제품 공급에 노력을 기울이고 있습니다.
GE Healthcare의 지속가능성(sustainability)은 환경 친화적인 제품 생산, 운영상의 효율 그 이상을 의미합니다. GE는 Ecomagination 이념을 통해 제품 수명 주기 전반에 걸쳐 제한된 자원을 효율적으로 사용하기 위하여 끊임없이 노력하고 있습니다.
대표적인 제품인 '옴니파큐(Omnipaque)'는 전세계 100여개 국가에서 8억 건 이상의 검사에 사용되고 있고, '비지파크(Visipaque)'는 X-RAY 조영제 중에 유일하게 혈액과 동등한 삼투압을 가진 안전성이 입증된 등장성 조영제입니다. '클라리스캔(Clariscan)'은 2018년 국내 출시한 거대고리형 가돌리늄 기반의 MRI 조영제로, 2017년 글로벌 출시 이후 580만명 이상의 환자에게 투여되고 있습니다. ‘소나조이드(Sonazoid)’는 마이크로버블의 지속시간을 획기적으로 연장시킨 초음파 조영제로 간암의 조기 진단에 기여하고 있습니다.
Korea QA Leader-PDx & Registered Pharmacist (품질보증부서장 및 수입관리약사)
GE Healthcare PDX(조영제) 사업부에서 Korea QA Leader로써 품질보증부서장 및 수입관리약사 업무를 담당/리딩해주실 인재를 채용합니다.
Individual Contributor Role이며 Global QA Director(외국인)에게 Reporting 해야 하는 포지션입니다.
근무지는 서울시 중구 서울스퀘어이며, 업무에 따라 경기도 용인시 수입자창고에 방문하여 창고관리, 직원관리, 식약처 실사 등의 업무를 담당하게 됩니다.
또한 업무상 영어활용 빈도가 높아 영어활용에 큰 부담이 없는 분을 채용합니다.
Bachelor’s degree or above with pharmacist license holder (MUST)
QA관련경력 510년 대리차장급
Knowledge of MFDS regulation, cGMPs, Quality Systems, product quality attributes and QA/QC compliance experience is preferred.
Good Command of English for effective oral/written communications.
Strong interpersonal skills for influencing and collaboration.
Frequent travel to the warehouse(경기도 용인) is required
This position is responsible for ensuring quality and regulatory compliance of a large and/or multi-modality facility (pharmaceutical, medical device) in PDx South Korea (with potential of supporting other countries in APAC), while driving process effectiveness and efficiency.
He/she represents GE Healthcare Pharmaceutical Diagnostics to external agencies and champions the evolution of the quality culture for the site which includes executing and driving site quality objectives, metrics, reporting and operating mechanisms.
Accountable for ensuring full quality and regulatory compliance of a facility with regulatory, GE and GDP requirements/regulations, while driving process effectiveness and efficiency at the site.
Ensures site audit readiness and hosts the Quality System audits and inspections (internal, customer and regulatory); prepares and executes Quality Management System reviews.
Maintains and improves all aspects of Site Quality Planning.
Oversees all Quality-related communications and training requirements for all site employees.
Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums.
Oversees product testing and release procedure for distribution in the region. Closely works with testing laboratories and external GDP partners.
Oversees the Corrective Action / Preventive Action activities and Complaint Handling Programs
Reports on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews.
Drives the definition of site quality objectives, metrics, reporting and operating mechanisms.
Owns site compliance assessment and remediation plans while influencing site execution, functional policy, local research and development programs, and communications and training requirements for Quality matters.
Influences site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines.
Influences quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics.
If managing a team, provides leadership and facilitates problem resolution, resource utilization, career counseling, mentoring and development of team members.
Participates in selected global initiatives to share best practices and leverage quality synergies.
Supports local NPI programs and quality issue resolution.
Acts as Management Representative for Quality at the Site.
Supports audits and oversight of third party suppliers, distribution service providers (warehouses, transport, wholesaler/dealer, channel partners, etc.)
Maintains positive relationships-liaisons with customers, local distributors and other business partners.
Bachelor's Degree of Science (Pharmacy, Chemistry, Biology or Biochemistry)
Minimum of 5 years working in a regulated pharmaceutical and/or medical device industry.
Minimum of 1 year supervisory/management or project leadership experience
Ability to communicate effectively in English and Spanish (both written and oral).
Demonstrated experience using word processing, spreadsheet, and presentation software.
Demonstrated understanding or aptitude to understand Pharmaceutical and Medical Device QMS requirements and regulatory requirements including but not limited to MFDS (Ministry of Food and Drug Safety), FDA CFR 21 820, ISO 13485, Good Distribution Practices (GDP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP).
Hands-on experience with MFDS (Ministry of Food and Drug Safety), FDA, QSR, ISO, MDD, GDP, GLP, GMP and/or other local or international quality systems requirements.
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required
Minimum of 5 years supervisory/management experience is preferred.
Proven process development and project management skills.
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.
Experience in a global, matrixed organization structure.
Excellent communication skills (written and oral)
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
Demonstrated working knowledge to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, etc.
Experience leading, implementing and accelerating change
Strong influencing, relationship building, mentoring & networking skills
Demonstrated collaboration & conflict resolution skills
Proven track record in performing & leading internal and external audits.
Exceptional analytical, problem solving & root-cause analysis skills
14.Experience with Quality Control lab process and its demands.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Relocation Assistance Provided: No