Position: Risk Assessment / Technical Document Specialist
Location: Lexington, MA
Duration: 12+ Months
This role will serve as a SME 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.
Primary Duties
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 Takeda 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
Responsibilities
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 and Experience Requirements
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
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
Key Skills, Abilities, and Competencies
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 role requires on-site presence for workshops, risk assessments, and stakeholder engagement
Strong proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Visio)
Benefits:
We offer a competitive compensation package that includes:
· [Pay Rate]: $80-90/hr per hour W2
o Note: Pay rate will be commensurate with experience.
· Medical for full time employees
· Dental, and Vision Insurance
· Life Insurance, Short-Term Disability, Long-Term Disability, etc.