Lab Quality Assurance Manager

Major Responsibilities

• 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 the tasks assigned by line manager

Qualifications: 

Education and Experience:

• 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

   

Skills and Competencies:

• 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 is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.

Novotech is a global full-service clinical Contract Research Organization (CRO).

Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.