Job
- Level
- Senior
- Job Field
- IT, Security, Test/QA
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Location
- Mainz
- Working Model
- Onsite
Job Summary
In this role, you will develop validation strategies for clinical systems, implement quality assurance projects, and ensure compliance with regulatory standards through innovative solutions and effective training.
Job Technologies
Your role in the team
- 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, and regulatory intelligence.
- 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.
- Überwachen Sie Qualitätsuntersuchungen und tragen Sie zur strategischen Ausrichtung der Abteilung bei, mit Fokus auf kontinuierliche Verbesserung.
- 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.
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Our expectations of you
Education
- Bachelor's degree in Information Systems, Medical, Pharmaceutical or Biomedical sciences.
Qualifications
- 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.
Experience
- 8+ years' experience in validation / quality, ideally in the pharmaceutical and biotech industry.
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What we offer
- 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 are determined by the specific role, location of employment, and also the selected candidate's qualifications and experience.
- 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.
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Benefits
Work-Life-Integration
More net
Topics that you deal with on the job
Job Locations
This is your employer
BioNTech AG
BioNTech is a cutting-edge immunotherapy company that is leading the way in developing new treatments for cancer, infectious diseases, and rare conditions. The company combines immunology research, modern therapeutic platforms, and bioinformatics tools to quickly develop new biopharmaceuticals.
Description
- Company Size
- 250+ Employees
- Founding year
- 2008
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech
Associate Director Digital Systems Compliance
- Location
- Mainz
- Working Model
- Onsite
- Diversity
- Open for all genders
- English Only
- English only required
