POSITION SUMMARY

The Manager, Global CSV provides expertise, guidance and leadership for the global validation and software assurance strategy and efforts to implement and support Global IT based systems for use in Cellectis facilities. The primary responsibility of this role is to provide strategy and plans to transform, execute, and sustain the Global Validation program incorporating a risk-based approach, including creation of Global Validation and Software Assurance procedures and processes to support GMP activities and adoption of Global Validation procedures and processes to support GMP activities. This is a hands-on strategic and execution role.

EDUCATION AND EXPERIENCE

• Bachelor’s degree, in a technical/science/mathematical field, required.
• Minimum 5-8 years validation experience in a biotech/pharmaceutical environment.
• Minimum 1 year experience managing validation functional area
• Experience with SAAS, IAAS, and PAAS software implementations.
• Enterprise Systems: Experience with using Off-the-shelf, Configured-Off-The-Shelf (COTs), and Bespoke Computerized Systems such as CRM, LMS, ERP (Oracle), LIMS, ELN, etc.
• Test Script Development: Experience writing and executing functional and performance test scripts.
• Previous leadership experiences required.

TECHNICAL SKILLS REQUIREMENTS / CORE COMPETENCIES

Validation & Compliance Expertise

• GAMP 5: Deep understanding of the Good Automated Manufacturing Practice framework.
• 21 CFR Part 11 / EU Annex 11: Expertise in electronic records and electronic signatures compliance.
• Computer Software Assurance (CSA): Proficiency with risk-based CSA approaches to streamline validation and incorporating into existing programs for efficiencies
• CSV Lifecycle Management: Proficiency in creating and managing validation documentation (URS, FS, DS, IQ/OQ/PQ, traceability matrix).

IT & Software Systems
System Integration: Knowledge of interfaces between automation systems and business platforms (e.g., MES

PHYSICAL POSITION REQUIREMENTS

Requires the ability to sit or stand at a computer for long stretches of time and type. Frequently operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. The person in this position needs to occasionally move about inside the office to access file cabinets and office equipment. May occasionally lift objects up to 20 pounds

Computer System Validation (CSV):

• Develop and manage CSV lifecycle documentation: Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, and Summary Reports.
• Ensure validation activities meet FDA, EMA, and other global regulatory standards.
• Identify and support the resolution of deviations noted during protocol execution; Take part in the resolution of departmental related deviations.
• Lead validation efforts for systems such as eQMS, EMS, ERP (Oracle), and other GMP-critical platforms.
• Responsible for authoring, revising, and maintaining Validation Master Plans of Global Computerized Systems.
• Validate integration points between automation systems and enterprise platforms (e.g., MES to ERP, MES to LIMS).

Computer Software Assurance (CSA):

• Conduct risk assessments to determine appropriate validation rigor based on system impact and complexity.
• Implement CSA principles to streamline validation of low-risk systems while maintaining compliance.
• Promote CSA methodologies to reduce documentation burden and enhance testing efficiency to ensure robust, efficient, and compliant processes.

Quality & Regulatory Compliance:

• Ensure systems comply with 21 CFR Part 11, EU Annex 11, GAMP 5, and internal SOPs.
• Follow departmental and Global/company-wide SOPs and policies, including Global Computerized System VMP and Policies.
• Lead investigations and CAPAs related to system failures or deviations.
• Present findings and results from completed validation deliverables in customer and internal audits, Support regulatory audits, as necessary.
• Requalification and periodic review schedule adherence for computerized systems and IT processes per procedure and established plans; Analyzes and summarizes periodic reviews of previously validated computerized systems and develop/implement protocols/changes based on outcome of the review.
• Support internal audits and regulatory inspections by providing validation documentation and system evidence.

Project & Team Management:

• Attend internal meetings to support computerized system validation topics.
• Coordinate validation schedules, resource allocation, and project timelines.
• Fosters a positive work environment.
• Manage cross-functional teams including QA, IT, automation engineers, and business users.
• Participates with CSV team to establish the annual goals and desired culture.
• Train and mentor staff on CSV, CSA, and automation compliance best practices.
• Serve as the subject matter expert to provide compliance and oversight to cross-functional team’s CSV and/or CSA projects.

Documentation & Change Control:

• Ensure traceability from requirements through testing and release.
• Maintain accurate and complete documentation for all validated systems.
• Review and approve change control requests impacting validated systems.

Continuous Improvement:

• Lead initiatives to enhance validation efficiency and system reliability.
• Monitor system performance and validation metrics to identify improvement opportunities.
• Stay current with evolving regulatory expectations and industry best practices.

Other duties / responsibilities as assigned
Travel up to 10% of the time.