CSV Documentation SME in Lexington, MA

• This role will serve as a SME across both IT systems and data integrity, ensuring solutions are compliant, inspection-ready, and operationally efficient.
• Responsible for modernizing technical system documentation across Quality Control Lab Systems and performing structured data integrity risk assessments to enable risk-based optimization of procedural controls.
• Will partner cross-functionally with Quality, IT, and Business Process Owners to:
• Will simplify, standardize, and modernize system documentation (e.g., FRS, SDCS, Admin SOPs, O&M procedures) in alignment with global templates
• Role will apply global Quality Risk Management (QRM) / ICH Q9 principles to evaluate data integrity controls such as audit trail review, backup/restore verification, and user access management
• Provide recommendations to optimize the frequency and design of controls

• Assess current-state system documentation across QC GxP systems
• Redesign and standardize documentation structure aligned to SDLC and validation expectations (e.g., FRS, SDCS, SOPs) and global templates
• Ensure documentation aligns with 21 CFR Part 11, Data integrity expectations, Internal validation, and SDLC and QMS standards
• Partner with system owners and SMEs to validate accuracy and usability of modernized documents.
• Identify opportunities to digitize, automate, or rationalize documentation and lifecycle processes in collaboration with QC IT team.
• Facilitate and execute structured risk assessments using QRM principles (e.g., ICH Q9 methodologies).
• Evaluate data integrity risks across system processes, including Administrative Audit trail Reviews, User access and privileges, Data backup and restore, Assess the effectiveness, redundancy, and burden of existing controls.
• Develop risk-based recommendations for Adjusting frequency of audit trail reviews, Optimizing backup/restore verification approaches, and rationalizing user account management processes.
• Document risk assessments with clear Risk statements, Impact/severity scoring, and detectability and mitigation strategies.
• Support development of remediation or optimization plans based on findings
• Align outputs with site DI program expectations and governance forums

• Bachelor’s degree in Science, Engineering, Information Technology, or related field (required)
• Experience in GxP-regulated pharmaceutical or biotech environments (required)
• Technical system documentation (FRS, SDCS, SOPs)
• Computerized Systems Validation (CSV) and system lifecycle management
• Experience leading or facilitating Quality Risk Management activities (preferred)
• Strong understanding of data integrity principles and regulatory expectations (required)
• Experience performing data integrity assessments or remediation activities (preferred)
• Experience working cross-functionally in a matrixed organization
• Data integrity regulations and expectations (ALCOA+, Part 11)
• Risk-based decision making and QRM methodologies

Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards.
Our success is a team effort.
Browse our website below for additional information on our company.

3407 W Martin Luther King Jr. Dr. Tampa, FL 33607
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”

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