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.