Manager* QA Compliance

Open for hire at one of the following locations –  Singapore. - Job ID: 6328 

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Manager* QA Compliance 

As a Manager* QA Compliance you are responsible for internal audits, external audits and regulatory inspection management and support Quality processes. You act as a check and balance for internal operations, help ensure alignment to global quality, internal and general GxP requirements for vendor and material management.

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, site operation readiness, including continuous improvements and ensure a state of inspection readiness 

• Lead inspection and audit preparations 

• Lead/coordinate the relevant forums/activities of the assigned Quality process (e.g. Quality Management Review, Quality Risk Review, 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