Job
- Level
- Senior
- Job Feld
- IT, Security, Test/QA
- Anstellung
- Vollzeit
- Vertragsart
- Unbefristetes Dienstverhältnis
- Ort
- Mainz
- Arbeitsmodell
- Onsite
Job Zusammenfassung
In dieser Position entwickelst du Validierungsstrategien für klinische Systeme, führst Qualitätssicherungsprojekte aus und sorgst für die Einhaltung von regulatorischen Standards durch innovative Lösungen und effektive Schulungen.
Job Technologien
Deine Rolle im 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, 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.
- 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.
Unsere Erwartungen an dich
Ausbildung
- Bachelor's degree in Information Systems, Medical, Pharmaceutical or Biomedical sciences.
Qualifikationen
- 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.
Erfahrung
- 8+ years' experience in validation / quality, ideally in the pharmaceutical and biotech industry.
Unser Angebot
- 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.
- 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.
Benefits
Work-Life-Integration
Mehr Netto
Themen mit denen du dich im Job beschäftigst
Job Standorte
Das ist dein Arbeitgeber
BioNTech AG
BioNTech ist ein Immuntherapie-Unternehmen, das bei der Entwicklung von Therapien für Krebs, Infektionskrankheiten und seltene Erkrankungen Pionierarbeit leistet. Das Unternehmen kombiniert Immunologieforschung, moderne therapeutische Plattformen und Bioinformatik-Tools, um die Entwicklung neuartiger Biopharmazeutika rasch voranzutreiben.
Description
- Unternehmensgröße
- 250+ Employees
- Gründungsjahr
- 2008
- Unternehmenstyp
- Etablierte Firma
- Arbeitsmodell
- Hybrid, Onsite
- Branche
- Pharma, Chemie, Biotech
Associate Director Digital Systems Compliance
- Ort
- Mainz
- Arbeitsmodell
- Onsite
- Diversität
- Für alle Personen geeignet (m/w/d)
- Nur Englisch
- Nur Englisch erforderlich
