SAP Solutions Architect

Proclinical is currently recruiting for an SAP Solutions Architect for a leading pharmaceutical company located in Research Triangle Park, NC. As the SAP Solutions Architect, you will provide management and oversight of ERP audit process to ensure SOX and GxP compliance. Work directly with internal and external audit teams to ensure compliance of ERP ecosystem and remediation of audit issues.

Job Responsibilities:

• Direct the planning and implementation and/or improvement of key ERP ecosystem initiatives in support of business operations to improve cost effectiveness, service quality, and business development.
• Support end-to-end solutioning: design, develop, test, and deploy SAP functionality and enhancements to meet business needs.
• In partnership with key vendors, provide operational support and system administration for implemented systems and services. Manages daily support of system through 3rd party AMS support services and contractors.
• Develop and document DR strategies for delivered systems and services.
• Provide technical guidance to other personnel.
• Coordinate activities across multiple projects, products, and technologies to ensure integration, consistent implementation, and compliance with technical standards.
• Establish configuration standards and ensures project documentation requirements are met.
• Partner with senior IT and business leaders to better understand the needs of the business, and work to ensure that resources and projects are properly aligned with business priorities.
• Review status of business applications and prepare recommendations for system improvements.
• Monitor and manage the application projects and report on the status.
• Ensures compliance of system (GxP, SOX, HIPAA, GDPR, etc) and that the appropriate processes and policies are developed and followed.

Skills and Requirements:

• BA/BS degree or equivalent required, advance degree is preferred.
• 12 years' experience successfully developing, implementing, and supporting information systems and services in FDA regulated environment.
• 8 years' experience in deployment and support of SAP ERP systems.
• A broad and deep knowledge of SAP ERP technologies and processes including SAP FI/MM/SDS/QA functions, ABAP, Basis, and Security.
• Working knowledge of RICEFW.
• Demonstrated experience using a GRC tool to manage SAP ERP.
• Demonstrated experience managing audit processes and internal and external auditors
• Demonstrated experience with strategies and technologies for application and data integration,
• Demonstrated experience planning, coordinating, and executing multiple projects concurrently.
• Demonstrated leadership skills to lead, develop and manage an IT organization through rapid growth and change. Experienced in staff career development, performance evaluation and team building.
• Demonstrated ability to develop and implement governance frameworks for IT Infrastructure, Applications, Security, Compliance, and general Operations/Support.
• Demonstrated experience in key compliance areas such as GxP, HIPAA, SOX, Sunshine Act, EU Data Protection and other compliance driven requirements.
• Ability to influence the thinking of or gain acceptance of others in sensitive situations.
• Experience in business case development (including cost benefit analysis) and budgeting.
• Demonstrated experience delivering technical solutions that require validation, documentation, training and support in a regulated environment.
• In depth knowledge of software development tools, practices, and lifecycle methodologies.
• Experience with the use of SDLC methodologies in project delivery.
• Candidate must have excellent written and oral communication skills. Proven ability to interact with Executive level team members and build relationships.
• Ability to function in a collaborative environment; sensitivity to others; high integrity; excellent judgment.

If you are having difficulty in applying or if you have any questions, please contact Jeff Chorpenning at (+1) 628-220-4284 or j.chorpenning@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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