Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company has a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience, as well as products and services in the Allergan Aesthetics portfolio.
Job Description
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 tomorrow's unmet medical needs in close collaboration with your colleagues.
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.
Qualifications
This is how you make a difference:
Required Qualification
•Graduated Engineer (FH) or bachelor's degree in natural sciences, several years of experience in drug product development or production or validation / qualification in the pharmaceutical field.
•Minimum of 5 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation, or compliance.
•Key leadership competencies to include relationship-building, ability to influence, knowledge of the business, sound judgment, conflict resolution, excellent interpersonal skills.
•Ability to provide innovative ideas to improve quality and compliance that create value, always seeking new information and insights (internal and external).
•Excellent communication capabilities and teamwork capacities, on a local and global level.
•Excellent knowledge of the English and the German language (spoken and written).
Additional Requirements
•Experience with development, oversight, validation, or governance of AI/ML-enabled technologies, advanced analytics platforms, automation solutions, or digital quality systems, including application of risk-based assurance and data integrity principles.
•Knowledge of emerging industry guidance related to AI/ML, computerized systems quality, and digital health technologies.
Conditions
•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
•A 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
