Manager, CSV

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.

POSITION RESPONSIBILITIES

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.

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 ↔ ERP).
• Data Integrity & Cybersecurity: Skills in audit trails, access control, and secure system architecture.

Risk Management & Testing

• Risk-Based Validation: Ability to assess system risk and determine appropriate validation rigor.
• Deviation & CAPA Management: Skills in investigating system failures and implementing corrective actions.

Project & Change Management

• Change Control Systems: Proficiency in managing validated systems through structured change control.
• Project Management Tools: Familiarity with tools like MS Project, JIRA, or Smartsheet.
• Agile/Waterfall Methodologies: Understanding of software development and validation lifecycle models.

Documentation & Regulatory Support

• Technical Writing: Strong skills in drafting validation protocols, reports, SOPs, and audit responses.
• Audit Readiness: Ability to prepare and present system documentation during regulatory inspections.

Core Competencies

• Receives assignments in the form of objectives, identifies resources needs and requirements.
• Follows processes, policies, and GMP SOPs in selecting methods and techniques to obtain results
• Able to carry out responsibilities with general guidance,
• Able to work on issues requiring evaluation of a variety of factors of diverse scope for analysis of situation or data.
• Exercises sound judgement in planning and/or making informed decisions. Able to create a strategy and execute on a risk-based approach to the validation of computerized systems globally,
• Able to pivot work priorities based on need from providing strategic input on plans to executing protocols and scripts,
• Able to collaborate with and influence global teams in core GxP functions QA, IT, Clinical, Operations, and Validation teams,
• Strong written and oral communication skills with ability to interact with various individuals and roles throughout the organization and with external consultants,
• Strong technical writing background; able to read/analyze/interpret common scientific/technical documents,
• Demonstrated ability to analyze, investigate and propose approaches to technical and regulatory issues,
• Results oriented, self-motivated, self-starter with flexibility to adapt to changing priorities and ability to manage 3+ projects/activities simultaneously,
• Strong ability and willingness to learn and work within a team environment,
• Fosters a positive work environment
• Highly ethical and transparent, with professional sensitivity and care for confidentiality.

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.