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Associate Director Digital Systems Compliance

BioNTech AG -
Mainz

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Details zur Stelle

Vollzeit

Qualifikationen

Informationssysteme
Erfahrung in der IT

Vollständige Stellenbeschreibung

Mainz, Germany; Munich, Germany | full time | Job ID: 11200

About the role:

As Associate Director of Digital Systems Compliance at BioNTech you will be responsible for defining and implementing validation strategies for clinical development systems, ensuring compliance with organizational and regulatory standards and driving regulatory compliance for digital systems through audit readiness, training compliance, access reviews, regulatory intelligence.

Your main responsibilities are:

Create and manage validation documents in accordance with SOPs, regulatory requirements, and industry guidelines
Apply technical, functional, business, and industry knowledge to guide teams within the department and support decision-making
Drive complex projects across departments, ensuring alignment with organizational objectives
Act as the main point of contact for validation issues, collaborating with various stakeholders and supporting the audit process
Oversee quality investigations and contribute to the department’s strategic direction, focusing on continuous improvement
Leverage technical expertise to address complex validation challenges across clinical systems
Be innovative and apply conceptual thinking to implement compliant and effective solutions that enhance cross-functional efficiency and maintain regulatory standards
Guide projects spanning multiple groups, influencing direction and allocating validation resources for successful outcomes that meet organizational goals
Run Audit readiness Program to get the department Inspection ready to reduce potential findings

What you have to offer:

Bachelor’s degree in Information Systems, Medical, Pharmaceutical or Biomedical sciences
8+ years’ experience in validation / quality, ideally in the pharmaceutical and biotech industry
Knowledge in computer system lifecycle activities, CSV / CSA and IT controls in a regulated environment
Well versed with CSV/CSA regulations like 21 CFR 11, Annex 11, EMA and ICH Guidelines, CSA Guidance etc.
Knowledge of IT Control methodologies, including a solid understanding of GxP guidance
IT knowledge (access control, account setup, file permission, database knowledge, cloud knowledge)
Good understanding of validation principles and practices and a risk-based approach
Ability to work in a team of multidisciplinary scientists and IT personnel, and operate effectively in a matrix environment; team player yet able to work independently

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.

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

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