Homeoffice IT Computer System Validation and Compliance Senior Manager bei Clinilabs, LLC.

JOB SUMMARY

The IT Computer System Validation and Compliance Senior Manager, is responsible for leading all validation processes and activities at Clinilabs. Working with Quality Assurance (QA), this individual will assist in developing and executing the CSV & Compliance program and assist in developing the strategic objectives for this cross-functional team partnering with business system owners across the organization. This position is responsible for assuring that Clinilabs GxP computerized systems are compliant with EMA, and ICH guidelines and U.S. GxP regulations.

RESPONSIBILITIES

• Develop standard operating procedures (SOP’s) and work instructions for computer system validation (CSV) including procedures for GxP system development life cycle, creation of validation packages and deliverables, CSV project management, and software vendor quality audit questionnaires.
• Act as IT CSV approver for project-related CSV documents on cross-functional teams that include Business Owners, IT CSV, IT System Administrators, System Owners, and Quality Assurance on projects including clinical data repositories, master data management systems, laboratory systems, and other systems supporting clinical or quality processes.
• Develop templates for CSV deliverables including validation plans, requirements specifications, design specifications, test scripts, and summary reports
• Participate in the development of Clinilabs IT data governance policies & procedures
• Proactively maintain IT compliance and data integrity across the Clinilabs GxP IT Portfolio, identifying risks and proactive initiatives
• Participate in the review of completed software quality audit questionnaires for software development methodology, testing standards, configuration management, patches, and security assessments
• Help develop and deliver training related to computer system validation and CSV testing
• Periodic Review of CSV packages for configuration reconciliation, change review, and validation maintenance
• Support inspections by regulatory agencies along with internal and external audits
• Participate in internal and external audits with responsibilities to prepare validation packages and defend bluebird’s computer system validation practices and system development life cycle
• Mentor and provide direction on CSV to members of project implementation teams
• Experience handling quality deviations, creating and raising quality issues, preparing CAPA’s and presenting compliance metrics
• Good writing skills with the ability to document solutions and create guidance for user training
• Knowledge of and adherence to Clinilabs policies and procedures

TRAVEL

• 5+ years managing CSV processes and staff
• 7+ years of Computer System Validation experience in a GxP clinical and laboratory environment
• Strong facilitation skills to develop consensus and clarity, ability to communicate and work independently with scientific and technical personnel
• Must have strong organizational skills and be able to execute and manage projects to completion
• Ability to work cross functionally with all levels of the organization
• Project management or ASQ, Black Belt/Green Belt certification is a plus
• Active participation/knowledge of ISPE, GAMP and/or ASQ standards a plus
• Strong understanding and working knowledge of FDA 21 CFR Part 11, 210, and 211, ICH Q8/9/10, and EU Annex 11 
• Proficient in MS Word, Excel, Power Point and other applications.
• Bachelor’s Degree in a technical discipline (Computer Science, Engineering, Chemistry/Biology)