Technical Consultant

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.

Primary Duties

• Modernizing technical system documentation across Quality Control Lab Systems
• Performing structured data integrity risk assessments to enable risk-based optimization of procedural controls
• Partnering cross-functionally with Quality, IT, and Business Process Owners
• Simplifying, standardizing, and modernizing system documentation in alignment with global templates
• Applying Takeda global Quality Risk Management (QRM) / ICH Q9 principles to evaluate data integrity controls
• Providing recommendations to optimize the frequency and design of controls

Responsibilities

• Technical Documentation Modernization (~50%)
• Assess current-state system documentation across QC GxP systems
• Redesign and standardize documentation structure aligned to SDLC and validation expectations
• 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
• Data Integrity Risk Assessments & Control Strategy Optimization (~50%)
• Facilitate and execute structured risk assessments using QRM principles
• Evaluate data integrity risks across system processes
• 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, 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

• Bachelor's degree in Science, Engineering, Information Technology, or related field (required)
• Experience in GxP-regulated pharmaceutical or biotech environments (required)
• Demonstrated experience with technical system documentation, computerized systems validation, and system lifecycle management
• Experience leading or facilitating Quality Risk Management activities (preferred)
• Strong understanding of data integrity principles and regulatory expectations
• 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
• Ability to translate complex technical systems into simplified, user-friendly documentation
• Expertise in evaluating system controls
• 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)
• EEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."