Associate Director – Digital Systems Compliance

BioNTech SE

Associate Director of Digital Systems Compliance at BioNTech responsible for validation strategies for clinical development systems and compliance with regulatory standards.

Posted 5/12/2026full-timeMainz • 🇩🇪 GermanySeniorWebsite

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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.

Benefits

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

validationquality assurancecomputer system lifecycle activitiesCSVCSAIT controlsGxP guidancevalidation principlesrisk-based approachaudit readiness

Soft Skills

collaborationdecision-makingproject managementstrategic thinkingcontinuous improvementconceptual thinkinginfluencingteamworkindependencecommunication