Job Description

　　Clinical Trial Services Site Korea as a part of Thermo Fisher Scientific is the world leader in clinical supply chain management and related support services. It has a world-wide network of packaging and distribution facilities.

　　Position Summary : Responsible for the Operations in the facility. Ensure systems and capacities are sufficient to meet the storage needs. Independently develop strategies and tactics for improving the operation efficiencies while improving service levels and profitability. Provide leadership and assume responsibility for the operation of the facility including development and management of people.

　　Responsibilities:

　　Responsible for monitoring and control of the production environment, facility hygiene, approval and monitoring of suppliers of materials that affect product quality, approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities, designation and monitoring of storage conditions for materials and products, retention of GxP records, and assist in the inspection, investigation, and taking of samples, in order to supervise factors which may affect product quality. Leading and ensuring of Facility is functioning accurately at efficient level.

　　Establish and maintain appropriate partner relations with responsibility. Responsible for authorization of written procedures and other documents, including amendments.

　　Supervise staff and ensure all work procedures and its related are conducted in accordance with cGMP standards and standard operating procedures.

　　Responsible for accurate instructions and ensure approved instructions relating to production operations and to ensure their strict implementation.

　　Ensure that products are produced and stored according to the SOP to acquire the required quality.

　　Develop and implement training plans and programs for staff. Ensure staff is adequately trained and their training records are well maintained, and that the required initial and continuing training of staff is carried out and adapted according to need.

　　Ensure that the production records are evaluated and signed by an authorized person.

　　Ensure the qualification and maintenance of department, premises, and equipment. Ensure that the appropriate validations (including process validation) are done.

　　Support audit and assurance within the area of Supply Chain.

　　Management and/or statutory performance reporting with responsibility.

　　Perform strategic sourcing and/or handle vendors to ensure it is effective, fair, equitable, driven, cost saving, and services performed according to service agreement.

　　Contribute to the preparation of related budget, responsible for operations budget and implementation of cost reduction initiatives.

　　Supervise and implement risk/change management with responsibility.

　　Maintain daily operations to ensure maximum productivity and cost efficiency and optimization of resources and capacity.

　　Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement.

　　Ensure that a timely and effective communication and blocking issue process exists to raise service and quality issues to the appropriate levels of management.

　　Responsible for all operational duties and process improvement in the Operations using PPI (Practical Process Improvement) business tools.

　　Supervise Company’s Facility and EHS with continuous improvement.

　　Support and/or implement related policies from Corporate or as instructed by local regulations.

　　Qualifications:

　　Bachelor’s degree in a relevant technical field.

　　10+ years of experience in Supply Chain/Logistics/Warehousing operations

　　Strong leadership with proven experience in People management and Facility Operations as head of team

　　Good knowledge of Quality in GxP environments, Audits, and Project management

　　Ability to communicate optimally across stakeholders and manage a team with varied strengths and good critical support to business.

　　Fluent in both English and Korean

　　Good working knowledge of Microsoft Office Suite (MS Word, Excel, PowerPoint)

　　Competencies:

　　Leadership

　　Steadiness

　　Communication

　　Organizational skills

　　Trouble shooting

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.