Quality Control jobs in United States

NCIS is establishing a new Stem Cell Therapy Hub (SCTH) as part of expansion of its Specialised Programmes and to become a Reference Centre of Excellence. We are looking for a Quality Control (QC) Team Lead for the QC department in the organisation.

The candidate will be responsible to oversee the Quality Control designated function which can include these areas - Raw Material Testing, In-process testing, Final Product Testing, Analytical Science and Technology, Environmental and QC Systems, for NCIS Specialised Programmes (specifically Cellular Therapy and Haematopoietic Stem Cell Transplant) and other provided services.

• Responsible to lead and direct the assigned Quality Control designated function.


• As Subject Matter Expert in assigned QC systems/processes/equipment to oversee the implementation and management of systems/processes.


• Owns QC related polices and procedure of the assigned QC processes which include product testing, materials testing, environmental monitoring, method development/qualification/validation, lab investigations, stability testing, LIMS, lab equipment qualification and/or calibration.


• Ensure timely completion of assigned activities which include testing, method development/qualification/validation, equipment qualification or computer systems validation as per agreed lead-time/milestones.


• Initiates/Reviews/approves procedures, documents, records, deviations, investigations, corrective action/preventive actions, changes controls and gaps assessment associated with the QC area(s) assigned.


• Ensure QC personnel are qualified and trained to perform assigned tasks.


• Support product/materials testing, methods qualification/validation activities, equipment qualification activities or other QC related activities as an executor, reviewer and/or approver.


• Ensure products are tested and assessed per applicable current GxP and regulations.


• Ensures that facilities, equipment, materials, processes and procedures that are applicable to QC comply to applicable, current GxP and regulations.


• Manage performance and development of direct reports to ensure achievement of organizational goals.


• Supports improvement initiatives, programs and projects driven from the Quality Management System.


• Escalates quality and compliance risks to QC and QA Management.

Note: Other responsibilities may be assigned by Head of Quality, or senior management

• Bachelor or higher, in Science, Pharmacy, Pharmaceutical Science, or equivalent, with preference of more than 6 years of relevant work experience in Quality Assurance Lead role in the pharmaceutical/biotechnology/medical device/healthcare industry, preferable with increasing people management responsibilities.


• Extensive knowledge in Quality Management System concepts


• Extensive knowledge in regulations and industrial guidance especially for stem cell / cell and gene therapy


• Excellent communication and able to engage stakeholders effectively from different functional units


• Critical thinking and problem-solving skill are of advantage.