BioNTech SE
Associate Director Digital Systems Compliance(m/w/x)
Full-timeOn-siteSenior
Mainz, München
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BIBioNTech SE
Associate Director Audit Management(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Leading global audits of clinical investigator sites and vendors for a biotech company. 6 years clinical auditing experience required. Oversight of contracted auditors and resource scheduling.
Requirements
- Academic degree in Life Sciences; advanced degree preferred
- At least 10 years clinical trial experience, including 6 years clinical auditing
- Proven leadership experience managing teams or projects for at least 3 years
- Deep knowledge of global GCP regulations and quality audit methodologies
- Oncology experience is an advantage
- Proficient in Microsoft Office software
- Proficient in Veeva
- Proficient in SharePoint
- Excellent English communication skills (written & verbal)
- Willingness to travel up to 10% of the time
Tasks
- Lead global audits of clinical investigator sites and vendor audits
- Ensure audit objectives align with risk-based strategies
- Coordinate and oversee audits by contracted auditors
- Schedule and select resources for contracted audits
- Review reports from contracted auditors
- Execute audits as the lead auditor for non-contracted audits
- Develop and track CAPA plans
- Assess effectiveness of CAPA plans
- Monitor trends in audit observations
- Identify areas for improvement
- Manage projects and relationships with audit vendors
- Support local health authority inspections
- Drive continuous improvement in audit management processes
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office
- Veeva
- SharePoint
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BIBioNTech SE
Associate Director Audit Management(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Leading global audits of clinical investigator sites and vendors for a biotech company. 6 years clinical auditing experience required. Oversight of contracted auditors and resource scheduling.
Requirements
- Academic degree in Life Sciences; advanced degree preferred
- At least 10 years clinical trial experience, including 6 years clinical auditing
- Proven leadership experience managing teams or projects for at least 3 years
- Deep knowledge of global GCP regulations and quality audit methodologies
- Oncology experience is an advantage
- Proficient in Microsoft Office software
- Proficient in Veeva
- Proficient in SharePoint
- Excellent English communication skills (written & verbal)
- Willingness to travel up to 10% of the time
Tasks
- Lead global audits of clinical investigator sites and vendor audits
- Ensure audit objectives align with risk-based strategies
- Coordinate and oversee audits by contracted auditors
- Schedule and select resources for contracted audits
- Review reports from contracted auditors
- Execute audits as the lead auditor for non-contracted audits
- Develop and track CAPA plans
- Assess effectiveness of CAPA plans
- Monitor trends in audit observations
- Identify areas for improvement
- Manage projects and relationships with audit vendors
- Support local health authority inspections
- Drive continuous improvement in audit management processes
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office
- Veeva
- SharePoint
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
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