Lead IT Audit Project Manager for Quality Assurance

vor 4 Wochen

Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit
Position Overview:

At AbbVie, we are dedicated to making a significant impact in the healthcare sector. With a workforce of approximately 50,000 globally and around 3,000 in Germany, we strive to address unmet medical needs through collaboration and innovation.

Your Role:

As a Senior QA IT Audit Project Manager, you will play a pivotal role in overseeing GxP IT inspection activities. Your responsibilities will include ensuring that AbbVie's quality systems and GxP IT systems, which support manufacturing and clinical operations, comply with relevant policies and regulations.

Key Responsibilities:

  • Oversee GxP IT inspection activities to ensure compliance with AbbVie's quality standards and regulatory requirements.
  • Lead and train teams in preparation for inspections, drawing on expertise from various technical disciplines.
  • Coordinate preparation activities for GxP pre-approval inspections at contract facilities.
  • Develop and implement corrective action plans to support successful inspection outcomes.
  • Communicate potential risks to management effectively, both verbally and in writing.
  • Provide guidance on Affiliate QA Policies and Procedures in line with applicable regulations.
  • Manage the global self-inspection program for AbbVie's GxP IT systems, including the internal audit schedule.
  • Conduct GxP IT Supplier Audits to ensure compliance in the management systems of suppliers.

Qualifications:

  • Bachelor's degree in a relevant field such as physical science, life science, or pharmacy.
  • Professional accreditation is preferred, such as ASQ Certified Quality Manager or PMP Certification.
  • Experience in Quality Assurance, Quality Control, or Regulatory roles within a regulated industry.
  • Strong understanding of international GxP regulations and pharmaceutical development processes.
  • Experience with regulatory inspections and direct interaction with agency inspectors.
  • Proven project management skills and the ability to communicate quality requirements clearly.
  • Demonstrated leadership capabilities, including relationship building and sound judgment.

What We Offer:

  • A diverse work environment where your contributions can make a difference.
  • An open corporate culture that values employee input.
  • Competitive salary and comprehensive benefits.
  • An extensive onboarding process with mentorship.
  • Flexible work arrangements to support work-life balance.
  • Access to corporate health management programs.
  • Opportunities for career advancement within an international organization.
  • A commitment to equality, diversity, and inclusion in the workplace.

At AbbVie, we believe in the power of collaboration and diversity to drive innovation and improve patient outcomes. We are committed to creating an inclusive environment where all employees can thrive.

  • Lead IT Quality Assurance Project Manager

    vor 4 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Position Overview:At AbbVie, we are driven by our commitment to enhancing global health care. With a workforce of 50,000 employees worldwide, including around 3,000 in Germany, we are dedicated to addressing tomorrow's unmet medical needs through collaboration and innovation.Your Role:As a Senior QA IT Audit Project Manager, you will play a pivotal role in...

  • Lead GxP IT Audit Project Manager

    vor 4 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Position Overview:At AbbVie, we are driven by a commitment to enhance global health care and improve the quality of life for patients. As a part of our dynamic team, you will have the opportunity to engage in meaningful work that makes a difference.Role Summary:We are seeking a Senior QA IT Audit Project Manager (all genders) for a permanent, full-time...

  • Lead GxP IT Audit Project Manager

    vor 4 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Position Overview:At AbbVie, we are driven by a commitment to improve global health care and enhance patients' quality of life. As a prominent international organization with a diverse workforce, we are looking for a Senior QA IT Audit Project Manager to join our team in a permanent, full-time capacity.Key Responsibilities:Oversee GxP IT inspection processes...

  • Lead GxP IT Audit Project Manager

    vor 4 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

    Position Overview:At AbbVie, we believe in the power of People, Passion, and Possibilities. This is more than just a role; it’s an opportunity to make a significant impact in the healthcare sector.As a part of a global organization with a workforce of 50,000, including approximately 3,000 in Germany, you will collaborate with dedicated professionals to...

  • Senior QA IT Audit Project Manager

    Vor 7 Tagen

    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 to ensure compliance with policies, procedures, and applicable government regulations.Key ResponsibilitiesManage GxP IT inspection...

  • Quality Assurance Audit Specialist

    vor 4 Wochen

    Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Bertrandt Vollzeit

    Job Title: Audit Operations AnalystCompany: BertrandtKey Responsibilities:Oversee the auditing process for the Quality Assurance team, managing all stages from initial planning to final reporting.Assist the lead auditor in gathering necessary documentation during the audit preparation phase.Identify and engage with relevant local and global stakeholders,...

  • Quality Assurance Audit Specialist

    vor 4 Wochen

    Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Bertrandt Vollzeit

    Job Title: Audit Operations AnalystCompany: BertrandtKey Responsibilities:Oversee the auditing process for the Quality Assurance team, managing all stages from initial planning to final reporting.Assist the lead auditor in gathering necessary documentation prior to audits.Identify and engage local and global stakeholders, including suppliers and healthcare...

  • Quality Assurance Audit Specialist

    vor 4 Wochen

    Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Bertrandt Vollzeit

    Job Title: Audit Operations AnalystCompany: BertrandtKey Responsibilities:Oversee the audit process for the Quality Assurance team, managing all stages from initial planning to final reporting.Assist the lead auditor in gathering necessary documentation during the audit preparation phase.Identify and engage with local and global stakeholders, including...

  • Quality Assurance Audit Specialist

    vor 4 Wochen

    Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Bertrandt Vollzeit

    Job Title: Audit Operations AnalystCompany: BertrandtKey Responsibilities:Oversee the auditing process for the Quality Medicine Auditing team, managing all stages from initial planning to final reporting.Assist the lead auditor in gathering necessary documentation during the audit preparation phase.Identify and engage with local and global stakeholders,...

  • Senior Project Lead

    Vor 6 Tagen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland ATS Automation Vollzeit

    Job SummaryWe are seeking a highly skilled and experienced Project Manager to lead our automation projects in the pharmaceutical and biotechnology industry. As a Project Manager, you will be responsible for planning, executing, and delivering projects on time, within budget, and to the required quality standards.Key ResponsibilitiesLead medium to large-sized...

  • Senior Project Lead

    vor 1 Woche

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland ATS Automation Vollzeit

    Job SummaryWe are seeking a highly skilled and experienced Project Manager to lead our automation projects in the pharmaceutical and biotechnology industry. As a Project Manager, you will be responsible for planning, executing, and delivering projects on time, within budget, and to the required quality standards.Key ResponsibilitiesLead medium to large-sized...

  • Quality Assurance Audit Specialist

    vor 4 Wochen

    Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Bertrandt Vollzeit

    Job Title: Audit Operations AnalystCompany: BertrandtKey Responsibilities:Oversee the audit process for the Quality Medicine Auditing team, managing all stages from initial planning to final reporting.Assist the lead auditor in gathering necessary documentation prior to audits.Identify and engage local and global stakeholders, including suppliers and...

  • Project Manager

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland Sauter-Cumulus Vollzeit

    Position Overview:We are seeking a highly skilled Project Manager to lead building automation projects from inception to completion at Sauter-Cumulus. As a key member of our team, you will be responsible for project management, client communication, budget monitoring, and quality assurance.Your Key Responsibilities:Review project requirements and...

  • Senior Quality Assurance Manager Production in Teilzeit

    vor 7 Stunden

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland BASF Vollzeit

    ÜberblickBASF bietet eine Vielzahl von Karrieremöglichkeiten für Qualitätsmanager in Teilzeit an. Wir suchen nach erfahrenen Fachleuten, die unsere Produktionsprozesse unterstützen und sicherstellen, dass unsere Produkte den höchsten Qualitätsstandards entsprechen.AufgabenAls Senior Quality Assurance Manager in Teilzeit werden Sie Teil unseres Teams...

  • Senior Quality Assurance Manager Production in Teilzeit

    vor 7 Stunden

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland BASF Vollzeit

    ÜberblickBASF bietet eine Vielzahl von Karrieremöglichkeiten für Qualitätsmanager in Teilzeit an. Wir suchen nach erfahrenen Fachleuten, die unsere Produktionsprozesse unterstützen und sicherstellen, dass unsere Produkte den höchsten Qualitätsstandards entsprechen.AufgabenAls Senior Quality Assurance Manager in Teilzeit werden Sie Teil unseres Teams...

  • Project Manager

    Vor 6 Tagen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland ATS Automation Vollzeit

    About the RoleWe are seeking a highly skilled and experienced Project Manager to lead our automation projects in the pharmaceutical and biotechnology industry. As a Project Manager, you will be responsible for planning and executing projects from concept to completion, ensuring that they are delivered on time, within budget, and to the required quality...

  • Project Manager

    vor 1 Woche

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland ATS Automation Vollzeit

    About the RoleWe are seeking a highly skilled and experienced Project Manager to lead our automation projects in the pharmaceutical and biotechnology industry. As a Project Manager, you will be responsible for planning and executing projects from concept to completion, ensuring that they are delivered on time, within budget, and to the required quality...

  • Project Manager Insulation

    Vor 6 Tagen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland Bohle-Gruppe Vollzeit

    Your Role:As a Project Manager for Insulation, you will lead and oversee technical insulation projects from conception to completion. Your responsibilities encompass all aspects of project management, ensuring successful execution within budget, schedule, and quality parameters.Key Responsibilities:Lead and manage projects independently, demonstrating strong...

  • Project Manager Insulation

    vor 2 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland Bohle-Gruppe Vollzeit

    Your Role:As a Project Manager for Insulation, you will lead and oversee technical insulation projects from conception to completion. Your responsibilities encompass all aspects of project management, ensuring successful execution within budget, schedule, and quality parameters.Key Responsibilities:Lead and manage projects independently, demonstrating strong...

  • Laboratory Technician for Quality Assurance

    vor 4 Wochen

    Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland Lipoid GmbH Vollzeit

    Position OverviewWe are seeking a dedicated Chemical Technical Assistant to contribute to our quality assurance efforts at Lipoid GmbH. In this role, you will be instrumental in upholding the integrity and excellence of our products.Key ResponsibilitiesConducting a variety of tests to evaluate product quality.Analyzing results and compiling data for...