- BioNTech Careers
- Manager First Level
- Quality Management, Quality Assurance
Become a member of the BioNTech Family!
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.
Director* Quality Control
Your main responsibilities are:
- Close collaboration with global Head of QC to implement all QC-related processes according to defined global standards
- Guide and oversee set-up and commissioning of analytical and microbiological QC labs including equipment qualification
- Support hiring for locally required QC employees and ensure proper training and qualification
- Ensure successful transfer/validation of time-critical compendial test methods
- Implement effective and reliable sample management and raw material testing and release processes
- Interface to global quality control organization to ensure state-of-art testing strategy and ensure continuous improvement
- Recruits, leads, motivates, and develops assigned direct reports in accordance with company leadership principles
- Ensure the implementation of testing processes with regard to cost efficiencies, ecology, quality, and safety to maintain the GMP status
- Approve starting materials, packaging materials, bulk and finished products (Drug Substance and Drug Product)
- Ensure that all necessary testing is carried out and the associated records evaluated
- Approve specifications, sampling instructions, test methods and other Quality Control procedures
- Approve and monitor any contract laboratories
- Ensure the qualification and maintenance of his/her department, premises and equipment
- Ensure that the appropriate validations are done
- Ensure that the required initial and continuing training of his/her department personnel is carried out and adapted according to need
- Measuring KPIs and supporting quality reviews
- Ensure that globally assigned activities (full cycle of drug substance and drug product testing) are performed in a timely manner while observing all internal and regulatory requirements
- Lead investigations for OOSs in collaboration with subject matter experts
- Ensure that change control procedures are initiated and executed appropriately
What you have to offer.
- Bachelor’s degree in relevant scientific discipline (e.g., Biology, Chemistry, Pharmacy) additional qualifications (MSc, PhD, MBA)
- At least 6-8 years of industry experience in pharmaceutical industry
- Experience supervising direct reports and organizing teams
- Regulatory and legal requirements experience\
- Working knowledge of relevant local and international regulations
- Strong understanding of pharmaceutical business and quality governance
- Broad knowledge and practical experience of analytical sciences and technologies
- Strong quality and analytical mindset
- Experience in hosting and collaborating with national or international regulatory agencies
- Fluent written and verbal English
- Strong leadership and excellent internal personal skill
- Sense of ownership and honesty (proactive handling of errors)
- Pronounced team & communication skills, self-driven and learning capacity
- Constructive work habits, flexibility, solution orientation, job ownership, quality appreciation
- Conceptual, analytical skills and ability to identify complex problem solutions
- Ability to plan and manage in a fast-paced environment
- Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
- Ability to navigate through ambiguity and rapid growth and adapt to change
- Honest, open minded, transparent, solution driven, continuous improvement focus
Benefits & Compensation.
Have we kindled your pioneering spirit?
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.
- 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.
- Please note that BioNTech will run a background check during the hiring process (criminal record certificate) in case you do not provide one
We are looking forward receiving your application.
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!