Aktuelle Jobs im Zusammenhang mit Lead GxP IT Audit Project Manager - Ludwigshafen am Rhein, Rheinland-Pfalz - AbbVie
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Lead GxP IT Audit Project Manager
vor 3 Monaten
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 position. This role is crucial in ensuring that our GxP IT systems comply 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 applicable regulations.
- Guide and train teams preparing for inspections, leveraging a diverse range of technical expertise.
- Coordinate pre-approval inspection preparations for contract facilities associated with regulatory submissions.
- Develop and implement corrective action plans to ensure successful inspection outcomes.
- Communicate compliance risks effectively to management, both verbally and in writing.
- Provide guidance on Affiliate QA Policies and Procedures in accordance with regulatory requirements.
- Manage the global self-inspection program for AbbVie's GxP IT systems, including scheduling 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, such as ASQ Certified Quality Manager or Project Management Professional, is preferred.
- Experience in Quality Assurance, Quality Control, Regulatory Affairs, or Validation within a regulated industry is essential.
- Familiarity with international GxP regulations and pharmaceutical development processes.
- Regulatory inspection experience with direct interaction with agency inspectors is advantageous.
- Strong project management skills and the ability to navigate complex regulatory environments.
- Excellent communication skills, with the ability to present and justify quality requirements clearly.
- Demonstrated leadership capabilities, including relationship building and sound judgment.
What We Offer:
- A diverse work environment where your contributions are valued.
- An open corporate culture that fosters collaboration.
- Competitive salary and comprehensive benefits package.
- A structured onboarding process with mentorship support.
- Flexible work arrangements to promote a healthy work-life balance.
- Access to corporate health management programs and wellness initiatives.
- Opportunities for career advancement within a global organization.
- Access to extensive professional development resources.
- A strong international network to support your career growth.
At AbbVie, we are dedicated to creating an inclusive workplace that values diversity and promotes equal opportunities for all employees. We believe that by embracing different perspectives and experiences, we can achieve the best outcomes for our patients.
