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quality assurance jobs near wiesbaden, he

Manager Systems Quality Assurance

BioNTech AG -
Mainz

Jetzt bewerben

Details zur Stelle

Vollzeit

Leistungen

Jobticket
Flexible Arbeitszeiten
Kostenfreies oder vergünstigtes Deutschland-Ticket

Qualifikationen

Qualitätsmanagement
Qualitätssicherung
Verhandlungsgeschick

Vollständige Stellenbeschreibung

Mainz, Germany | full time | Job ID: 11375

About the Job:

As Manager Systems Quality Assurance you will be part of the global team „Global Quality Contracts“. In this role you will be responsible for the negotiation of quality contracts with our national and international contract manufacturing organizations, laboratories and others. With the afore mentioned you will support the qualification as well as oversight of our suppliers, service providers and vendors in the clinical and commercial field.

Your Contribution:

Creation, negotiation as well as continuous maintenance, periodic review and revision of quality assurance agreements with our national and international partners (e.g. contract manufacturing organizations, laboratories….) as well as coordination with the relevant stakeholders both internal and external
Training of the operational departments with regards to the contents of quality assurance agreements
Participate in building a robust supply chain and contractual framework and support the optimization of processes within the lifecycle of contracts
Independent evaluation and processing of external documents / notifications of contract acceptors and partners as well as communication with operational teams
Alignment with different local and global stakeholder groups (e.g. legal, procurement, operational quality assurance, qualified persons, CMC)

A Good Match:

Several years of professional experience (>3 years) in the pharmaceutical industry, preferably in quality assurance / quality management
Quality mindset and profound knowledge of the relevant US & EU regulations, EMA, FDA and other regulatory standards in the biotechnological / pharmaceutical industry for investigational medicinal products and commercial products (especially EU-GMP, 21 CFR Part 211, ICH Guidelines, GDP)
Deep expertise in the negotiation of quality assurance agreements e.g. with contract manufacturing organizations, laboratories etc.
Experience in the support of manufacturing of investigational medicinal products for clinical studies of phase I to III and commercial products
Resilient personality, ability to connect people and distribute information
Good combination of strategic skills; ability to make profound decisions in a highly dynamic and flexible environment
Strong communication and collaboration skills as well as diplomacy in dealing with national and international partners in both German and English
High team spirit, effective stakeholder management and collaboration skills

Your Benefits:

It's our priority to support you:

Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).

Job ID 11375 (please always specify if you have any questions)

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com

Jetzt bewerben

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