Contingent Consultant

EDV Werke is looking for a Contingent Consultant

Working Model: Remote

Form of cooperation: B2B Contract

Role Summary:

We are seeking a Contingent Consultant to join our team in remote position. We are seeking a Contingent Consultant to join our Identity Governance and Administration (IGA) team. This role is responsible for coordinating and managing changes to our identity management systems within a highly regulated environment, with a strong emphasis on GxP compliance. The ideal candidate will possess excellent organizational skills and the ability to collaborate effectively across multiple teams, including IT, Quality Assurance, and various business units, to ensure all changes are executed accurately and in full compliance with industry standards.

Responsibilities:

• Primary Liaison for GxP Compliance: Serve as the focal point for coordinating all GxP-related changes within the MyAccess team, ensuring regulatory alignment and seamless change execution
• Change Calendar Management: Maintain a detailed change calendar, ensuring all relevant parties are informed of upcoming changes, potential impacts, and critical timelines
• System Compliance Oversight: Ensure that all changes to identity and access management systems are planned, approved, tested, and implemented in alignment with GxP requirements and regulatory standards
• Stakeholder Collaboration: Work closely with stakeholders, including Quality Assurance, IT, and business teams, to ensure timely approval and execution of changes
• Progress Monitoring with Development Team: Work directly with MyAccess SailPoint developers, business analysts, and application owners to manage and monitor the progress of changes and updates, ensuring compliance with GxP and other regulatory requirements
• External Communication Coordination: Ensure effective communication between the MyAccess project team and external stakeholders regarding changes, project milestones, and quality assurance needs
• Change Management Best Practices: Provide guidance and support to team members on best practices for change management and compliance with internal processes and GxP regulations
• Process Documentation and Maintenance: Oversee the development, documentation, and maintenance of change management processes concerning GxP compliance
• Quality Assurance Partnership: Partner with the QA team to verify that all changes are thoroughly tested to meet GxP, regulatory, and performance standards before implementation
• Compliance with IT Governance: Ensure changes align with platform requirements, GxP regulatory requirements, and IT governance standards
• Detailed Change Tracking: Maintain detailed records of all changes, including tracking incidents, resolutions, and outcomes in accordance with GxP documentation standards
• Status Reporting on Changes: Create and maintain reports on the status of changes, with a focus on their impact on system performance, user experience, and compliance with GxP regulations
• Post-Implementation Review and Process Improvement: Provide post-implementation reviews and contribute to continuous process improvement by identifying areas for enhancement, especially concerning regulatory compliance
• Continuous Learning and Industry Awareness: Stay informed of the latest developments in IAM, including SailPoint IIQ best practices and evolving GxP regulations
• Proactive Process Optimization: Proactively identify areas for improvement within the change management process to enhance efficiency and GxP compliance

Requirements:

• Educational Background in Technology: Holds a Bachelor’s degree in Information Technology or possesses equivalent experience relevant to the field.
• Expertise in GxP-Regulated IAM Systems: Demonstrates experience in coordinating or managing changes within GxP-regulated Identity and Access Management (IAM) systems, particularly with expertise in SailPoint IIQ.
• In-Depth Knowledge of Core IAM Principles: Understands core Identity and Access Management (IAM) principles, including user lifecycle management stages like Joiner, Mover, Leaver, governance frameworks, and access controls
• Comprehensive Knowledge of the Software Development Lifecycle: Possesses thorough knowledge of the software development lifecycle, with expertise in Development (DEV), Validation (VAL), and Production (PROD) environments
• Proficiency in GxP Change Management: Skilled in GxP change management, ensuring modifications align with strict regulatory compliance requirements
• Expertise in Quality Assurance Processes: Proficient in Quality Assurance (QA) standards, including protocols such as Engineering Change Impact Review (EICR), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Adherence to Standard Operating Procedures: Follows and enforces Standard Operating Procedures (SOPs) to ensure consistency and regulatory compliance across IAM and development activities
• Exceptional Communication and Stakeholder Coordination: Exhibits outstanding communication and coordination skills, adept at managing multiple stakeholders to ensure regulatory compliance and efficient project execution
• Precision in Documentation and Regulatory Reporting: Skilled in managing detailed documentation and reporting to meet GxP regulatory and compliance standards with accuracy and thoroughness
• European Time Zone Availability: Available to work within European time zones to ensure collaboration with geographically aligned team members and stakeholders
• Cultural Alignment with European Work Ethic: Adopts a European-centered approach to work, aligning with regional communication styles, work habits, and business practices
• Specialized Experience in the Pharmaceutical Industry: Holds significant industry experience within the pharmaceutical sector, familiar with unique regulatory and operational standards critical to the role
• Key Contributor to Team Success: Plays an integral role within the team, actively contributing to objectives and supporting overall project success
• Accountability for Documentation Timeliness and Accuracy: Ensures all documentation is completed, reviewed, and approved within established timelines, supporting project accuracy and compliance
• Proactive Ownership and Initiative: Demonstrates a strong sense of ownership over tasks, proactively engaging with team members and stakeholders to ensure project alignment and progress

Benefits:

• A competitive salary package and performance-based bonuses
• Opportunities for professional development and career progression
• Development opportunities including budget or trainings and workshops
• A dynamic and supportive work environment