Manager Systems Quality Assurance
Mainz, Germany | full time | Job ID:9123
This position is limited to 2 years! As Manager Systems Quality Assurance you will be part of our global team „Systems QA 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.
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
Participate in building a robust supply chain and contractual framework and support the optimization of processes within the lifecycle of contracts
Alignment with different local and global stakeholder groups (e.g. legal, procurement, operational quality assurance, qualified persons, CMC)
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
High carefulness and accuracy in the way of working, conscientiousness, organizational talent, and initiative
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
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