Risk Assessment​/Technical Document Specialist

Risk Assessment / Technical Document Specialist

This role will serve as a subject matter expert across both IT systems and data integrity, ensuring solutions are compliant, inspection-ready, and operationally efficient. 12 Month contract with potential to extend.

Onsite Expectations:
For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting working on projects, it is a minimum 3 days a week onsite, there will be times to be on site 4-5 days as needed.

This contractor role is 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. The consultant will partner cross-functionally with Quality, IT, and Business Process Owners to:

• Simplify, standardize, and modernize system documentation (e.g., FRS, SDCS, Admin SOPs, O&M procedures) in alignment with global templates
• Apply the client 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

1. Technical Documentation Modernization (~50%)

• 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, 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

2. Data Integrity Risk Assessments & Control Strategy Optimization (~50%)

• 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
• Rationalizing user account management processes
• Document risk assessments with clear:
• Risk statements
• Impact/severity scoring
• Detectability and mitigation strategies
• Support development of remediation or optimization plans based on findings
• Align outputs with site DI program expectations and governance forums

Education Bachelor's degree in Science, Engineering, Information Technology, or related field (required)

Experience Experience in GxP-regulated pharmaceutical or biotech environments (required) Demonstrated experience with:

• Technical system documentation (FRS, SDCS, SOPs)
• Computerized Systems Validation (CSV) and system lifecycle management
• 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

Strong knowledge of:

• Data integrity regulations and expectations (ALCOA+, Part 11)
• Risk-based decision making and QRM methodologies

Ability to translate complex technical systems into simplified, user-friendly documentation

Expertise in evaluating system controls (audit trails, access, backups, interfaces)

Strong facilitation skills for risk assessments and cross-functional workshops

Analytical thinking with ability to challenge legacy practices and drive simplification

Effective communication skills across technical and non-technical stakeholders

Ability to operate independently with minimal oversight in a fast-paced environment

Complexity and Problem Solving

Applies risk-based judgment to evaluate compliance vs. operational efficiency trade-offs

Makes recommendations that may significantly change control strategies or reduce operational burden

Balances regulatory expectations with pragmatic, scalable solutions

Works across multiple systems, functions, and stakeholders simultaneously

Other Job Requirements

Role requires on-site presence for workshops, risk assessments, and stakeholder engagement

Strong proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Visio)