Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies requirements.
Manage and supervise a team of ten or more direct reports who are focused on tactical, operational and some strategic activities within quality department.
Oversee Quality Engineering team functional roles, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports
Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of our products.
Participate on internal, inter-facility and vendors/suppliers quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, FDA and ISO requirements.
Drive the Manufacturing operations initiatives, qualification and validation activities for product or technology transfers.
Lead Quality improvement initiatives and align the organization to meet Quality goals and Objectives.
Requirements
Bachelors degree required with minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience in Pharmaceutical / Medical Device Manufacturing
Familiar with ISO 13485
Experience in managing a team size of 15-20 Engineers
Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
Preferably in a quality assurance or test related capacity.
Good written reporting skills and excellent English (oral and written reporting skills).
Able to multi-tasking and willing to take challenges.
Good communication skills to leverage multicultural and multi-departmental teams.
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239