Welcome to AbbVie! As part of an international company with ca. 57,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Together, we break through – as (Senior) Software Validation Engineer Quality Assurance (all genders)

The (Senior) Software Validation Engineer - Quality Assurance (QA) provides quality oversight and subject matter expertise for GxP computerized systems across GMP, GLP, GCP, and PV-regulated areas within the R&D organization. The role is responsible for interpreting regulatory and quality requirements, guiding risk-based software validation and Computer Software Assurance (CSA) activities, supporting data integrity compliance, and ensuring inspection readiness through effective validation lifecycle management, governance, training, and business partner support.

Make your mark:

• Provide interpretation, guidance, and training for business partners regarding software qualifications / validation and related regulatory regulations / guidelines, including data integrity and AbbVie policies / procedures.
• Support Business System Owner and Business SME with their IT software projects and goals.
• Advise project teams, Business System Owners, and Business SMEs on risk-based CSV / CSA strategy, validation planning, testing approach, traceability, and documentation expectations for new systems and system changes.
• Review / approve various software qualification / validation documentation, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.
• Provide technical guidance, coaching, and training to RDQA colleagues and business partners on CSV / CSA, data integrity, validation, and quality system expectations.
• Defend software qualification / validation during regulatory authority inspections and third-party audits.
• Support business in understanding the process of inspection/ audit responses.
• Recommend a plan of action for satisfactory resolution of quality and regulatory compliance issues.
• Participate in CAPA activities, provide support to event owners and Business System Owners, review and approve related records.
• Provide guidance, direction, and support to R&D QA staff.
• Participate in process improvement projects and assist with the development of compliance plans and strategies.