Hybrid Manager Quality Assurance - Processes and Systems (Mainz, RP, DE, 55131) bei BioNTech

Mainz, Germany   |   full time   |   Job ID: 9399 

The Manager Quality Assurance Processes and Systems supports to establish, maintain, and optimize a unified global quality management system (QMS) that spans all regulated areas in alignment with company policies and procedures as well as international regulations and guidelines.

Your main responsibilities are: 

This position contributes to a proactive risk-based quality culture by implementing quality by design principles to support the organization objectives and goals by:

• Designing, maintaining, and optimizing quality assurance processes for the QMS (e.g., deviation management, change management, training management)
• Managing QMS-related documents
• Managing trainings concerning quality assurance processes
• Advising regulated specialist departments regarding QMS‐related topics
• Establishing and monitoring quality objectives as well as metrics

What you have to offer: 

• Completed vocational training as scientific technical assistent or similar with at least 3 years working experience in a regulated area (e.g., GCP, GCLP, GVP), or university/polytechnical degree in pharmacy, chemistry, biology, biochemistry, medicine, life sciences or similar
• Experience in a regulated environment in the pharmaceutical, biotechnology or CRO Industry (e.g., GCP, GCLP, GVP), preferably in quality-related functions
• Understanding of quality principles, GxP principles and their impact on a company’s development and business
• Knowledge of regulations and guidelines (including ICH, FDA, EMA) related to clinical trial development and post approval of medicinal products
• Experience in quality assurance functions such as quality/audit/inspection/risk management
• Fluent in English (written and spoken). Ideally fluent in German (written and spoken)
• Ability to conduct analysis, collaborate with stakeholders in a matrix organization, and manage competing priorities
• Computer literacy and knowledge in the use of electronic quality management systems

Your Benefits:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending 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 via our online form.

Please note:

Only applications sent via our online form shall be considered. 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.

We are looking forward receiving your application.