Senior GCP Compliance Auditor

vor 4 Wochen

Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit
Join AbbVie as a Senior GCP Compliance Auditor

We are seeking a highly skilled and experienced Senior GCP Compliance Auditor to join our team at AbbVie. As a Senior GCP Compliance Auditor, you will play a critical role in ensuring the compliance of our global operations with regulatory requirements and industry standards.

Key Responsibilities:
  • Interpret and apply regulatory requirements, guidelines, and policies to ensure compliance with GCP regulations
  • Plan, organize, and lead audits to evaluate vendor R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records, and controls for compliance with GCP regulations
  • Lead or participate in investigator site audits to ensure compliance with global regulatory requirements and AbbVie requirements
  • Lead Global System and Supplier Audits to evaluate internal AbbVie areas for compliance with applicable SOPs and local regulations
  • Effectively communicate audit results, both orally and in writing
  • Review corrective action plans/audit responses for adequacy and approve if adequate
  • Evaluate the potential risk of compliance deficiencies
  • Review policies and procedures and suggest improvements
  • Maintain effective communication of project-related information
  • Provide training and consulting services to the organization to ensure GCP compliance
  • Escalate potential quality issues to management
Requirements:
  • Bachelor's Degree or equivalent education and typically 12 years of experience, Master's Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience
  • Degree in a physical science, life science, nursing, pharmacy, or equivalent experience required
  • 5-7 years of pharmaceutical industry experience in Quality Assurance or Regulatory Affairs
  • 5-7 years of clinical research and development
  • Minimum 2 years of QA auditing experience (GCP Auditing preferred)
  • Ability to work independently as well as a team member
What We Offer:
  • A diverse work environment where you can have a real impact
  • An open corporate culture
  • An attractive salary
  • An intensive onboarding process with a mentor at your side
  • Flexible work models for a healthy work-life balance
  • Corporate health management that offers comprehensive health and exercise programs
  • Company social benefits
  • A wide range of career opportunities in an international organization
  • Top-tier, attractive development opportunities
  • A strong international network

We are committed to equality, equity, diversity, and inclusion (EED&I) and strive to create an inclusive culture where all employees feel valued and respected. We believe that a diverse and inclusive workplace is essential to our success and look forward to welcoming talented individuals like you to our team.

  • Senior GCP Compliance Auditor

    vor 3 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Join AbbVie as a Senior GCP Compliance AuditorWe are seeking a highly skilled and experienced Senior GCP Compliance Auditor to join our team at AbbVie. As a Senior GCP Compliance Auditor, you will play a critical role in ensuring the compliance of our global operations with regulatory requirements and industry standards.Key Responsibilities:Interpret and...

  • Senior GCP Compliance Auditor

    vor 3 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Join AbbVie as a Senior GCP Compliance AuditorWe are seeking a highly skilled and experienced Senior GCP Compliance Auditor to join our team at AbbVie. As a Senior GCP Compliance Auditor, you will play a critical role in ensuring the compliance of our global operations with regulatory requirements and industry standards.Key Responsibilities:Interpret and...

  • Senior GCP Compliance Auditor

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Job Title: Senior GCP Compliance AuditorAbout the Role:We are seeking a highly skilled Senior GCP Compliance Auditor to join our team at AbbVie. As a Senior GCP Compliance Auditor, you will be responsible for ensuring that our company's products and services meet the highest standards of quality and compliance.Key Responsibilities:* Interpret and apply...

  • Senior GCP Compliance Auditor

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    About the RoleWe are seeking a highly skilled Senior GCP Compliance Auditor to join our team at AbbVie. As a key member of our compliance team, you will be responsible for ensuring that our global operations comply with regulatory requirements and industry standards.Key ResponsibilitiesInterpret and apply regulatory requirements and industry standards to...

  • Senior Compliance Auditor

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    About the Role:We are seeking a highly skilled Senior Compliance Auditor to join our team at AbbVie. As a Senior Compliance Auditor, you will be responsible for ensuring that our company's operations comply with all relevant regulations and guidelines.Key Responsibilities:Interpret and apply relevant regulations, guidelines, and policies to ensure...

  • Senior Compliance Auditor

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    About the RoleWe are seeking a highly skilled Senior GCP Compliance Auditor to join our team at AbbVie. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global regulations and guidelines.Key ResponsibilitiesInterpret and apply applicable regulations, guidelines, policies, and proceduresPlan, organize, and...

  • Senior Software Engineer

    Vor 7 Tagen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland educcare Vollzeit

    About the RoleWe are seeking a Senior Software Engineer with expertise in Cloud Infrastructure to join our team at {company}. The ideal candidate will have a proven track record in designing and implementing scalable, secure, and efficient cloud-based systems.Key ResponsibilitiesDesign and develop cloud infrastructure solutions using AWS, Azure, or Google...

  • Senior IT-Systemadministrator

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland DIS AG Vollzeit

    Ihre AufgabenWir suchen einen Senior IT-Systemadministrator, der die Virtualisierungsumgebung (VMware) steuert und die Backup-Prozesse (Veeam) verwaltet.Der Senior IT-Systemadministrator ist verantwortlich für die Sicherstellung des reibungslosen Betriebs von Servern, Netzwerk und Storage.Er ist eigenverantwortlich für die Planung, Betreuung und...

  • Senior IT-Systemadministrator

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland DIS AG Vollzeit

    Ihre AufgabenWir suchen einen Senior IT-Systemadministrator, der die Virtualisierungsumgebung (VMware) steuert und die Backup-Prozesse (Veeam) verwaltet.Der Senior IT-Systemadministrator ist für die Sicherstellung des reibungslosen Betriebs von Servern, Netzwerk und Storage verantwortlich.Er ist eigenverantwortlich für die Planung, Betreuung und...

  • Senior Data Engineer

    vor 3 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland RHEINPFALZ Mediengruppe Vollzeit

    Senior Data Engineer PositionWir suchen einen erfahrenen Senior Data Engineer, der unsere Data Platform weiterentwickeln und optimieren kann. Als Teil unseres Data & Analytics Teams werden Sie an der Entwicklung von Datenstrukturen und -prozessen mitwirken und unsere Datenqualität und -integrität sicherstellen.Deine Aufgaben:Leitung und Durchführung von...

  • Senior Data Engineer

    vor 3 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland RHEINPFALZ Mediengruppe Vollzeit

    Senior Data Engineer PositionWir suchen einen erfahrenen Senior Data Engineer, der unsere Data Platform weiterentwickeln und optimieren kann. Als Teil unseres Data & Analytics Teams werden Sie an der Entwicklung von Datenstrukturen und -prozessen mitwirken und unsere Datenqualität und -integrität sicherstellen.Deine Aufgaben:Leitung und Durchführung von...

  • Senior Quality Assurance Manager Production in Teilzeit

    vor 3 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland BASF Vollzeit

    Job DescriptionBASF Nutrition & Health offers a comprehensive product and service portfolio for human and animal nutrition, the pharmaceutical industry, the ethanol industry, and the flavor and fragrance industry. With innovative solutions and modern technologies, we support our customers in improving the profitability of their business and offering products...

  • Senior Quality Assurance Manager Production in Teilzeit

    vor 3 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland BASF Vollzeit

    Job DescriptionBASF Nutrition & Health offers a comprehensive product and service portfolio for human and animal nutrition, the pharmaceutical industry, the ethanol industry, and the flavor and fragrance industry. With innovative solutions and modern technologies, we support our customers in improving the profitability of their business and offering products...

  • Senior Quality Assurance Manager

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    About the RoleWe are seeking a highly skilled Senior QA IT Audit Project Manager to join our team at AbbVie. As a key member of our quality assurance team, you will be responsible for managing GxP IT inspection activities and ensuring compliance with policies, procedures, and government regulations.Main Responsibilities:Manage GxP IT inspection activities to...

  • Senior Quality Assurance IT Audit Project Manager

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Join AbbVie's Team as a Senior QA IT Audit Project ManagerWe are seeking a highly skilled Senior QA IT Audit Project Manager to join our team in Ludwigshafen. As a key member of our team, you will be responsible for managing GxP IT inspection activities to ensure compliance with policies, procedures, and applicable government regulations.Key...

  • Senior Software Engineer

    vor 3 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland BASF Digital Solutions GmbH Vollzeit

    About the RoleWe are seeking a highly skilled Senior Software Engineer to join our team at BASF Digital Solutions GmbH. As a Senior Software Engineer - SAP HANA Expert, you will be responsible for designing, developing, and maintaining SAP software applications and systems like SAP GTS and SAP GTS, edition for SAP HANA.Key ResponsibilitiesDesign and develop...

  • Senior IT Audit Project Manager

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Join AbbVie's Team as a Senior QA IT Audit Project ManagerWe are seeking a highly skilled and experienced Senior QA IT Audit Project Manager to join our team in Ludwigshafen. As a Senior QA IT Audit Project Manager, you will be responsible for managing GxP IT inspection activities to ensure compliance with policies, procedures, and applicable government...

  • Senior IT Audit Project Manager

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Join AbbVie's Team as a Senior IT Audit Project ManagerWe are seeking a highly skilled Senior IT Audit Project Manager to join our team at AbbVie. As a Senior IT Audit Project Manager, you will be responsible for managing GxP IT inspection activities to ensure compliance with policies, procedures, and applicable government regulations.Key...

  • Senior Software Engineer

    Vor 7 Tagen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland BASF Vollzeit

    Job SummaryWe are seeking a highly skilled Senior Software Engineer - Cloud Architect to join our team. As a key member of our cloud infrastructure team, you will be responsible for designing and implementing cloud-based solutions that meet the needs of our business.ResponsibilitiesDesign and implement cloud-based solutions using Amazon Web Services (AWS)...

  • Senior Quality Assurance IT Audit Project Manager

    vor 3 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Join AbbVie's Team as a Senior QA IT Audit Project ManagerAt AbbVie, we're committed to making a difference in the lives of patients worldwide. As a Senior QA IT Audit Project Manager, you'll play a critical role in ensuring the quality and integrity of our IT systems, ensuring compliance with regulatory requirements and industry standards.Key...