職位描述
職位描述：
Job Responsibilities
? Lead, coach, develop and assess the Quality Control Laboratory team. Review subordinate’s performance, set objectives, priorities and develop career plans and conduct performance assessments.
? Lead and manage the QC laboratory to ensure the uniformity, consistency, reliability, reproducibility, quality and integrity testing to support GMP functions, such as Raw Materials, Analytical Chemistry, Biochemistry, Viral & Safety tests and Technical Services.
? Manage, implement and execute quality systems such as laboratory operations, cell bank management, raw material management, sample management and equipment qualification management.
? Align the laboratory operation with corporate quality policy such as product testing, CAPA, Change control, discrepancy investigations, stability testing, LIMS, lab equipment calibration providing support to QC Systems.
? Take a lead role in providing guidance and support on aberrant and OOS result investigations and to ensure staffs become competent assessor in this area.
? Ensure that documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness
? Author/Contribute to CMC sections of Annual Progress Reports and Annual Product Reviews
? Manage performance and development of direct reports providing regularly scheduled feedback throughout the year to ensure achievement of organizational and department goals and a productive environment.
? Proactively use scientific literature and guidelines to solve problems.
? Ensures test methods are qualified/validated to support production of products for clinical or commercial use.
? Identify and interact with outside manufacturers and contract test labs.
? Provide complete data analysis and be able to drive projects to completion using data generated in the design of new experiments and/or critical assessment.
? Contribute to sections of regulatory submissions (primarily IND, BLA etc.).
? Ability to recognize, trouble-shoot, and resolve problems with equipment or individual assays.
Job Requirements:
? Minimum 4+ years’ experience in biotechnology industry in quality management position.
? In-depth knowledge of scientific, analytical, manufacturing and regulatory principles (PIC/s, ICH TFDA, EMEA and FDA).
? Ability to manage multi-disciplinary teams.
? Ability to make contributions across departments, and to effectively interact across departments in pursuit of company goals.
? Excellent verbal and written communication skills; able to communicate in English
? Thorough knowledge of GMP practices and regulations.
? Experience in directing and leading successful quality control laboratory functions to achieve regulatory approval.
? Prior method validation and qualification experience will be a plus.
