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Risk Assessment/Technical Document Specialist

Nature and Scope of Job

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.

Addtional 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 enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the consultant shall:

• Work onsite at the Lexington, MA facility a minimum of 3 days per week, with 4 to 5 days during onboarding and as needed for workshops, risk assessments, and stakeholder engagement.
• Sit or stand for prolonged periods at a desk and work on a computer in an environmentally controlled setting.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message, and must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the person assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.