Risk Assessment​/Technical Document Specialist

Risk Assessment/Technical Document Specialist

The Risk Assessment/Technical Document Specialist serves as a subject matter expert across both IT systems and data integrity for a Takeda quality control lab systems engagement, ensuring solutions are compliant, inspection ready, and operationally efficient. This is a 12 month contract engagement based in Lexington, MA, with the potential to extend, and is hybrid onsite. The consultant should plan to be onsite 4 to 5 days a week for the first few weeks for onboarding and training.

After onboarding, the role requires a minimum of 3 days a week onsite, with 4 to 5 days as needed.

Primary Responsibilities

• Assess current state technical system documentation across Quality Control GxP systems, including FRS, SDCS, Admin SOPs, and O&M procedures.
• Redesign and standardize documentation structure aligned to SDLC and validation expectations and global templates.
• Ensure documentation aligns with 21 CFR Part 11, data integrity expectations, and internal validation, SDLC, and QMS standards.
• Partner with system owners and subject matter experts to validate the accuracy and usability of modernized documents.
• Identify opportunities to digitize, automate, or rationalize documentation and lifecycle processes in collaboration with the QC IT team.
• Apply Takeda global Quality Risk Management (QRM) and ICH Q9 principles to evaluate data integrity controls such as audit trail review, backup/restore verification, and user access management.
• Facilitate and execute structured risk assessments using QRM principles, including ICH Q9 methodologies.
• Evaluate data integrity risks across system processes, including administrative audit trail reviews, user access and privileges, and data backup and restore.

Additional Responsibilities

• Assess the effectiveness, redundancy, and burden of existing controls, and provide recommendations to optimize the frequency and design of controls.
• Develop risk based recommendations for adjusting audit trail review frequency, optimizing backup/restore verification approaches, and rationalizing user account management processes.
• Document risk assessments with clear risk statements, impact and severity scoring, detectability, and mitigation strategies.
• Support development of remediation or optimization plans based on findings, and align outputs with site data integrity program expectations and governance forums.

Qualifications

• Experience in GxP regulated pharmaceutical or biotech environments (required).
• Demonstrated experience with technical system documentation (FRS, SDCS, SOPs) and Computerized Systems Validation (CSV) and system lifecycle management.
• Strong understanding of data integrity principles and regulatory expectations, including ALCOA+ and Part 11 (required).
• Experience leading or facilitating Quality Risk Management activities (preferred).
• Experience performing data integrity assessments or remediation activities (preferred).
• Experience working cross functionally in a matrixed organization.
• Ability to translate complex technical systems into simplified, user friendly documentation.
• Expertise evaluating system controls such as audit trails, access, backups, and interfaces.
• Strong facilitation skills for risk assessments and cross functional workshops.
• Analytical thinking with the 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.
• Applies risk based judgment to evaluate compliance versus operational efficiency trade offs, and works across multiple systems, functions, and stakeholders simultaneously.
• Strong proficiency in Microsoft Office tools, including Word, Excel, PowerPoint, and Visio.

Education & Certifications

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

Working Conditions

The working conditions described here are representative of those that must be met by a consultant to successfully perform the essential responsibilities and functions of this role, and are not meant to be all inclusive. Reasonable accommodation may be made to…