Job Description

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

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

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 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

Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate\'s qualifications and experience.

How to apply:

Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.

Please note:

• Only applications sent via our online form shall be considered.
• Only Candidates with the right qualifications and relevant experience shall be shortlisted and
• Incomplete applications shall be rejected.
• BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it\'s a match!

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