Lab Quality Assurance Manager

• Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role.
• Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
• Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
• Monitor updates for regulatory legislations and/or guidelines.
• Conduct review of documents, procedures, facilities… etc., to ensure compliance to the regulatory requirements.
• Perform review and quality assurance for reports and documents to be submitted to the regulatory departments.
• Review the responses of the audit or inspection findings for appropriateness and completeness.
• By following approved procedure and schedules, conducting audits either independently or collaboratively with other QA auditors.
• Ensure timely completion of routine QA procedures.
• Work collaboratively with each department head in the assessment of vendors' qualifications.
• Assisting in project related or non-project related audits/inspections conducted by customer or regulatory authorities.
• Write and issue audit reports or any non-conformances form in accordance with SOPs.
• Ensure that audit findings are clearly made to the relevant project team members, department heads and upper management.
• Participate in the investigation of non-compliance, problem reporting, or complaint issues. Follow through to verify corrective/preventive actions are appropriate and enforced as well as tracking and monitoring performances of the actions taken before case closed.
• Perform housekeeping on documents generated as a result of QA activities. Provide inputs to the development of departmental quality system process. Manage SOPs according to company policy or regulatory agencies.
• Conduct provisional tasks assigned by line manager.
• Establish training plan for junior QA specialist and provide training to ensure compliance with company policy and regulatory requirements.
• Perform the tasks assigned by line manager

• Bachelor's degree in a scientific discipline. Advanced degree is a plus.
• 4 or more-year of QA, GLP（bioanalysis lab,or CAP experience is preferred.
• At least 1 year experience in management role is a plus

• Good knowledge of regulatory requirements for GLP and CAP
• Good communication skills.
• English speaking,listening, reading and writing skills.
• Computer skills.
• Detail orientated.
• Good leadership skills

Novotech