Becton Dickinson
Senior Clinical Project Manager(m/w/x)
Full-timeWith HomeofficeSenior
Karlsruhe
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DEDE09 Agilent Technologies Deutschland GmbH
Lead Internal Auditor – Global Quality(m/w/x)
Waldbronn
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading risk-based internal audits of QMS compliance for medical device and pharma operations. 8+ years in regulated quality systems and internal auditing required. Audit strategy development, complex multi-site audits.
Requirements
- Bachelor’s degree in science, engineering, or related field
- Advanced degree preferred
- 8+ years’ experience in regulated quality systems
- 8+ years’ experience in internal auditing
- 8+ years’ experience in regulatory compliance
- Experience in pharmaceutical and/or medical device industries
- 5+ years’ experience as Lead Internal Auditor
- Audit planning experience
- Audit execution experience
- Auditor management experience
- ISO 13485 Lead Auditor certification
- Experience auditing full product lifecycle
- Experience auditing design processes
- Experience auditing manufacturing processes
- Experience auditing laboratories
- Experience auditing post-market surveillance
- Experience auditing support processes
- Strong analytical skills
- Strong risk-based thinking skills
- Strong problem-solving skills
- Strong communication skills
- Ability to influence across global matrix organizations
- Proven ability to manage multiple audits
- Proven ability to manage multiple priorities
- Maintain professionalism during audits
- Maintain integrity during audits
- Maintain sound judgment during audits
- Willingness to travel globally up to 50%
Tasks
- Plan and lead risk-based internal audits
- Conduct audits in pharmaceutical and medical device operations
- Serve as Lead Auditor for complex, cross-functional, and multi-site audits
- Assess QMS compliance with ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements
- Develop audit strategies, plans, and reports
- Communicate audit findings, trends, and improvement opportunities
- Identify systemic issues and drive continuous improvement
- Provide guidance on regulatory and quality requirements
- Train and coach sites on self-directed audits
- Support inspection and audit readiness activities
- Prepare for regulatory authority inspections and Notified Body audits
- Assist with nonconformity and observation responses
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of DE09 Agilent Technologies Deutschland GmbH 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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DEDE09 Agilent Technologies Deutschland GmbH
Lead Internal Auditor – Global Quality(m/w/x)
Waldbronn
Full-timeWith Home OfficeSenior
Nejo AI Summary
Leading risk-based internal audits of QMS compliance for medical device and pharma operations. 8+ years in regulated quality systems and internal auditing required. Audit strategy development, complex multi-site audits.
Requirements
- Bachelor’s degree in science, engineering, or related field
- Advanced degree preferred
- 8+ years’ experience in regulated quality systems
- 8+ years’ experience in internal auditing
- 8+ years’ experience in regulatory compliance
- Experience in pharmaceutical and/or medical device industries
- 5+ years’ experience as Lead Internal Auditor
- Audit planning experience
- Audit execution experience
- Auditor management experience
- ISO 13485 Lead Auditor certification
- Experience auditing full product lifecycle
- Experience auditing design processes
- Experience auditing manufacturing processes
- Experience auditing laboratories
- Experience auditing post-market surveillance
- Experience auditing support processes
- Strong analytical skills
- Strong risk-based thinking skills
- Strong problem-solving skills
- Strong communication skills
- Ability to influence across global matrix organizations
- Proven ability to manage multiple audits
- Proven ability to manage multiple priorities
- Maintain professionalism during audits
- Maintain integrity during audits
- Maintain sound judgment during audits
- Willingness to travel globally up to 50%
Tasks
- Plan and lead risk-based internal audits
- Conduct audits in pharmaceutical and medical device operations
- Serve as Lead Auditor for complex, cross-functional, and multi-site audits
- Assess QMS compliance with ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements
- Develop audit strategies, plans, and reports
- Communicate audit findings, trends, and improvement opportunities
- Identify systemic issues and drive continuous improvement
- Provide guidance on regulatory and quality requirements
- Train and coach sites on self-directed audits
- Support inspection and audit readiness activities
- Prepare for regulatory authority inspections and Notified Body audits
- Assist with nonconformity and observation responses
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of DE09 Agilent Technologies Deutschland GmbH 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
DE09 Agilent Technologies Deutschland GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen bietet Geräte, Software, Dienstleistungen und Verbrauchsmaterialien für analytische Labore und trägt zur Verbesserung der Lebensqualität bei.
Not a perfect match?
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