Manager SAP I&T Computerized System

The Opportunity

You will contribute to the I&T organization to provide important Computerized System Assurance (CSA) services. You will provide current Quality Management System (cQMS) compliance oversight for systems and services; computer validation services; audit and inspection support services. Main words and phrases that describe the performance of this role include compliance, quality, efficient, consistency, value added, leadership, organized, collaborative, and customer-focused . These words were chosen because how we deliver our services is just as important as what we deliver. This is a working manager role; you will participate directly in the support of your customers while leading your team of contractors. We are looking to develop close collaboration and productive relationships with the CSL Digital Quality function, the many I&T support towers, and our third-party support partner.

Team Management

• Lead a CSA team of contractors to support the defined functions
• Mentor team members
• Ensure support for assigned I&T towers and projects

Audit and Inspection Support Services

• Provide back room support for audits and inspections with the possibility of speaking directly with the auditor/inspector, but this will not be common.
• Maintain support materials to facilitate review of systems and services
• Accountable for the remediation of audit findings related to IT quality, regulatory compliance, and information security

cQMS Compliance Oversight

• Provide guidance to I&T towers and teams related to the cQMS
• Work within the global I&T organization and partners with DQ to ensure processes and standards are suitable for the business and are compliant with GxP regulations.
• Provide I&T compliance oversight for non-GxP impact systems and will partner with DQ in ensuring compliance for GxP systems
• Mentor staff in the SDLC methodology. This may include conducting group training sessions.
• Consult with DQ and the I&T Governance group, supports the maintenance and ongoing development of procedures to ensure compliance to relevant GxP manufacturing and data integrity regulations.
• Assure that corrective and preventative actions for the support area are addressed.
• Ensure cQMS compliance of computer systems through the plan, build, maintenance, and decommissioning phases of the system lifecycle.
• Conduct assessments of functional areas, to identify areas for continuous improvement
• Provide overall QA oversight for site infrastructure qualification
• Approval of specified lifecycle documentation
• Ensure your team are trained appropriately
• Dispositions specified I&T Change Controls
• Maintain excellent relationships with I&T and DQ customers, and third-party support partner

Computer Validation Services

• Consult with DQ and the I&T Governance group, supports the maintenance and ongoing development of CSV procedures.
• Ensure a scientific and risk managed approach is taken toward validation
• Overall accountability for the validation effort
• Determine the validation strategy
• Manage the validation schedule, Validation SMEs, and coordinate testing resources.
• Partner with DQ to provide advice and participates in project team activities to the validation of our computerized business applications and other software systems.

Education

• Bachelor's degree with study in scientific, engineering, or computer systems focus is preferred. Work experience can replace this requirement

Experience

• 5+ years of experience in computer systems compliance
• 2+ year of experience in management
• SAP Project-based Experience
• Expert level knowledge of GAMP 5
• Expert level knowledge of GxP regulations globally as they pertain to I&T
• Demonstrated experience leading complex, multi-site/functional groups
• Life sciences industry experience preferred but other regulated industry experience is also accepted
• Experience working across a range of countries and cultures

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.