BioNTech SE
Manager QA Compliance(m/w/x)
Full-timeOn-siteSenior
Mainz
New Job?Nejo!
Your personal AI career agent
BOBoehringer Ingelheim
Senior Corporate Quality Manager / Quality Audits & Inspections(m/w/x)
Ingelheim am Rhein, Biberach
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
Global quality audits of pharma sites and CMOs, assessing GxP standards. Bachelor's degree and long-term GMP experience required. On-site audits, 4-day work week.
Requirements
- Bachelor's, Master's, or Doctoral degree in Pharmaceutics, Biopharmaceutics, Engineering, or Science
- Long-term practical experience in GMP-regulated environments (Quality Control, Manufacturing, Engineering, Drug Development)
- Experience in Quality Assurance or regulatory compliance management
- Strong knowledge of GxP, ISO, CSV, and regulatory compliance regulations
- Exposure to authority inspections (FDA, EMA, USDA or international)
- Experience in matrix organizations
- Demonstrated audit skills with appropriate qualifications
- Ability to identify and resolve GxP-related issues
- Adherence to company and regulatory standards
- Proficiency in data analytics, including AI
- Strategic and conceptual thinking
- Cross-functional and cross-country collaboration
- Ability to drive compliance initiatives and programs
- English proficiency with excellent written and oral communication
- German or French language skills (advantageous)
- Applications from persons with severe disabilities warmly welcomed
Tasks
- Schedule, prepare, conduct, and report on global quality audits
- Audit Boehringer Ingelheim sites, global functions, and processes
- Audit Contract Manufacturing Organizations (CMOs)
- Perform regular, for-cause, and mock-PAI audits
- Assess implementation of Boehringer Ingelheim’s quality and GxP standards
- Ensure compliance with regulatory requirements
- Identify, communicate, and escalate compliance issues and risks
- Establish and ensure adequate CAPA plans post-audit
- Verify effective implementation of CAPAs during subsequent audits
- Monitor industry trends and regulatory agency interpretations
- Stay updated with evolving global GxP standards
- Provide insights and guidance on GxP requirements
- Lead or contribute to project teams for compliance improvement
- Define and maintain components of the Quality Audit and Inspection System
- Ensure system alignment with best practices
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Tools & Technologies
- GxP
- ISO
- CSV
- FDA
- EMA
- USDA
- AI
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim 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.
Not a perfect match?
- Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NCE(m/w/x)
Full-timeOn-siteSeniorBiberach, Ingelheim am Rhein - Boehringer Ingelheim
.CMO Quality Assurance Manager(m/w/x)
Full-timeOn-siteExperiencedIngelheim am Rhein - BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
.Manager Global Quality Assurance CSV(m/w/x)
Full-timeOn-siteExperiencedMainz
BOBoehringer Ingelheim
Senior Corporate Quality Manager / Quality Audits & Inspections(m/w/x)
Ingelheim am Rhein, Biberach
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
Global quality audits of pharma sites and CMOs, assessing GxP standards. Bachelor's degree and long-term GMP experience required. On-site audits, 4-day work week.
Requirements
- Bachelor's, Master's, or Doctoral degree in Pharmaceutics, Biopharmaceutics, Engineering, or Science
- Long-term practical experience in GMP-regulated environments (Quality Control, Manufacturing, Engineering, Drug Development)
- Experience in Quality Assurance or regulatory compliance management
- Strong knowledge of GxP, ISO, CSV, and regulatory compliance regulations
- Exposure to authority inspections (FDA, EMA, USDA or international)
- Experience in matrix organizations
- Demonstrated audit skills with appropriate qualifications
- Ability to identify and resolve GxP-related issues
- Adherence to company and regulatory standards
- Proficiency in data analytics, including AI
- Strategic and conceptual thinking
- Cross-functional and cross-country collaboration
- Ability to drive compliance initiatives and programs
- English proficiency with excellent written and oral communication
- German or French language skills (advantageous)
- Applications from persons with severe disabilities warmly welcomed
Tasks
- Schedule, prepare, conduct, and report on global quality audits
- Audit Boehringer Ingelheim sites, global functions, and processes
- Audit Contract Manufacturing Organizations (CMOs)
- Perform regular, for-cause, and mock-PAI audits
- Assess implementation of Boehringer Ingelheim’s quality and GxP standards
- Ensure compliance with regulatory requirements
- Identify, communicate, and escalate compliance issues and risks
- Establish and ensure adequate CAPA plans post-audit
- Verify effective implementation of CAPAs during subsequent audits
- Monitor industry trends and regulatory agency interpretations
- Stay updated with evolving global GxP standards
- Provide insights and guidance on GxP requirements
- Lead or contribute to project teams for compliance improvement
- Define and maintain components of the Quality Audit and Inspection System
- Ensure system alignment with best practices
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Tools & Technologies
- GxP
- ISO
- CSV
- FDA
- EMA
- USDA
- AI
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim 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.
About the Company
Boehringer Ingelheim
Industry
Pharmaceuticals
Description
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
Not a perfect match?
- BioNTech SE
Manager QA Compliance(m/w/x)
Full-timeOn-siteSeniorMainz - Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NCE(m/w/x)
Full-timeOn-siteSeniorBiberach, Ingelheim am Rhein - Boehringer Ingelheim
.CMO Quality Assurance Manager(m/w/x)
Full-timeOn-siteExperiencedIngelheim am Rhein - BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
.Manager Global Quality Assurance CSV(m/w/x)
Full-timeOn-siteExperiencedMainz