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Lead IT Quality Assurance Project Manager

vor 3 Monaten


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 ensuring that our GxP IT systems align with regulatory standards and support our manufacturing and clinical operations.

Key Responsibilities:

  • Oversee GxP IT inspection activities to ensure compliance with AbbVie's quality management system and relevant regulations.
  • Guide and mentor teams in preparation for inspections, fostering collaboration among technical experts.
  • Coordinate pre-approval inspection activities for contract facilities involved in regulatory submissions.
  • Develop and implement corrective action plans to address compliance issues and ensure successful audit outcomes.
  • Communicate potential risks to management effectively, both verbally and in writing.
  • Provide expert guidance on Affiliate QA Policies and Procedures in accordance with applicable regulations.
  • Manage the global self-inspection program for AbbVie's GxP IT systems, including the scheduling of internal audits.
  • Conduct GxP IT Supplier Audits to verify that suppliers maintain compliant management systems for GxP IT products and services.

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 Project Management Professional (PMP).
  • Experience in Quality Assurance, Quality Control, Regulatory Affairs, or Validation within a regulated industry.
  • In-depth knowledge of international GxP regulations and pharmaceutical development processes.
  • Experience with regulatory inspections and direct interaction with agency inspectors.
  • Strong project management capabilities and excellent communication skills.
  • Demonstrated leadership skills, including cultural awareness and the ability to influence at all organizational levels.

What We Offer:

  • A diverse work environment where your contributions can make a significant impact.
  • An open corporate culture that values collaboration and innovation.
  • Competitive salary and comprehensive benefits package.
  • An extensive onboarding process with mentorship support.
  • Flexible work arrangements to promote a healthy work-life balance.
  • Robust corporate health management programs.
  • Opportunities for career advancement within a global organization.
  • Access to top-tier professional development resources.
  • A strong international network of professionals.

At AbbVie, we are committed to fostering an inclusive workplace that values diversity and equity. We believe that by embracing different perspectives and experiences, we can achieve the best outcomes for our patients and our community.