Manager* CTSM Excellence SOP
Open for hire at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, London. - Job ID: 6457
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
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.
Manager* CTSM Excellence SOP
Your main responsibilities are:
- Developing, harmonizing, driving and to document activities around CTSM SOPs
- Leading efforts to gather and create SOP requirements or process improvements
- Acting as supportive source of knowledge for all SOPs and internal policy documents
- Leading the analysis and recommendations for SOP effectiveness
- Driving day-to-day activities to ensure the accuracy, governance, and maintenance of SOPs
- Supporting the communication and trainings of SOPs to operational teams
What you have to offer:
- Relevant professional experiences (usually +3 years) in Pharmaceutical or Biotech or any other equivalent industry setting
- Experience in writing SOPs, processes, procedures, user manuals and work instructions (or equivalent combination of education and experience)
- Understanding and familiarity with scientific terminology, regulatory writing styles, standards & procedures.
- Good Understanding of Quality Management Systems
- Good understanding of GMP and GCP principles
- Ability to lead without authority to ensure documents move through the required review and approval steps
- Experience in compilation of regulatory documents preferred
- Standard office software proficiency (e.g., MS Office)
- Business-professional English language skills
Preferred Requirements:
- Above average attention to detail, accuracy, and strong communication and interpersonal skills, verbal and written
- High level communication skills when it comes to interaction with representatives from different functional departments including contact with functional leads
- Ability to solve multi-layered and dynamic activities
- Self-motivated with strong problem-solving and learning skills
- Able to accurately work under pressure in a versatile environment
- Willing and able to take over responsibility and ownership
- Ability to create independent analyses and develop new solutions
- Excellent organizational and communicative skills
- Openness to explore on new topics for setting up the trend
Benefits for you
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.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
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.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, London. Apply now for your preferred job and location through our careers site.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!