Manager* QA Operations

Open for hire at one of the following locations –  Singapore. - Job ID: 6327 

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We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Manager* QA Operations 

As a Manager* QA Operations you are responsible to help ensure that operations are in alignment and compliant with global Quality, internal and general GxP requirements. You ensure that raw materials are tested meeting specifications and DS, DP are produced meeting the specifications per the dossier and approved appropriately for release. 

Your main responsibilities are: 
 

• Responsible to lead and direct the assigned Quality Process  

• Provide QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations  

• Provide QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations  

• Implement, maintain and review the assigned Quality Process according to applicable current GxP and regulations  

• Own policies and procedures of the assigned Quality Process where applicable 

• Partner with global and communicate to functions to ensure the assigned Quality Process is executed according to established policies and procedures 

• Review/approve and provide inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process 

• Ensure deviations from assigned Quality Process are documented and investigated  

• Ensure QA personnel are qualified and trained to perform assigned tasks  

• Support technology transfer activities

• Develop strategies for assigned Quality Process to be fit for purpose, including continuous improvements and ensure a state of inspection readiness 

• Support inspection and audit preparations 

• Participate in Quality Management Review, Quality Risk Management and APQR 

• Escalate quality and compliance risks to Head of Department, QA 

• Support improvement initiatives, programs and projects of the assigned Quality Process 

• Build, maintain and develop a team to support the deliverables of this assigned Quality Process

What you have to offer:

• University degree/Advanced Degree in Science (medicine, pharmacy, chemistry, biotechnology, biology or equivalent)

• At least 10 years’ professional working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry with >3 years people management experience 

• Extensive knowledge in Quality Management System concepts and strong understanding of pharmaceutical business and regulatory governance/framework 

• Experiences with collaborations with global multidisciplinary functions involved in drug development and manufacturing 

• Ability to be agile and effectively collaborate in a dynamic, cross-functional environment  

• High degree of conscientiousness and diligence  

• Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment 

• Self-starter and learning capacity  

• Sense of ownership and honesty (proactive handling of errors)  

• Ability to navigate through ambiguity and rapid growth and adapt to change, especially in a start-up environment 

• Expectation to be hands on, interactive and display practical leadership 

• Good communication skills  

• Fluent in written and verbal English