We are seeking an experienced
SR IT Business Analyst & GxP Systems Manager to lead business analysis, compliance, and systems support activities across a portfolio of regulated
GLP (Good Laboratory Practice) and
GMP (Good Manufacturing Practice) computerized systems. This role serves as a strategic IT partner to Quality Assurance (QA), Regulatory Affairs (RA/Reg Ops), Manufacturing, Quality Control, Process Development, Validation, and other GxP business functions.
The ideal candidate combines strong business analysis expertise with hands-on experience supporting validated GxP systems, Computer System Validation (CSV), Computer Software Assurance (CSA), data integrity, and regulatory compliance. This individual will play a key role in driving technology solutions that enhance operational efficiency while maintaining inspection readiness and compliance with global regulatory requirements.
Key ResponsibilitiesBusiness Analysis & Stakeholder Partnership- Serve as the primary IT business partner for QA and Regulatory Affairs/Operations teams, supporting Quality Management Systems (QMS), quality documentation platforms, regulatory systems, and other GxP applications.
- Lead requirements gathering activities through workshops, stakeholder interviews, and process analysis sessions.
- Translate business needs into clear, testable, and compliant system requirements, user stories, process maps, data flow diagrams, and functional specifications.
- Facilitate collaboration between business stakeholders, IT teams, validation personnel, and vendors to ensure successful solution delivery.
Project & Systems Leadership- Lead and support medium to large-scale initiatives involving regulated systems and business processes.
- Develop strategic roadmaps and long-term system improvement plans aligned with organizational objectives.
- Oversee enhancement requests, defect remediation, system upgrades, integrations, and lifecycle management activities.
- Drive prioritization efforts while balancing business value, compliance requirements, and resource constraints.
GxP Compliance, Validation & Inspection Readiness- Partner closely with QA and Validation teams to ensure requirements remain traceable throughout the system lifecycle.
- Support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities, including:
- User Requirements Specifications (URS)
- Risk Assessments
- Traceability Matrices
- Test Scripts and Protocols
- Validation Summary Reports
- IQ/OQ/PQ Execution Support
- Ensure compliance with regulatory requirements including FDA 21 CFR Part 11, GAMP 5, ALCOA+, and applicable internal quality procedures.
- Maintain inspection readiness by ensuring validation documentation, change records, and supporting evidence remain current and readily accessible.
System Administration & Operational Support- Support validated systems through proper access management, role administration, periodic reviews, and audit readiness activities.
- Coordinate system backups, data retention, archiving, and disaster recovery processes for regulated environments.
- Partner with IT infrastructure teams, vendors, and business stakeholders to maintain system reliability, availability, and security.
- Support vendor qualification, audits, and ongoing compliance monitoring activities.
Quality, Manufacturing & Laboratory Systems Support- Provide validation and compliance oversight for laboratory, manufacturing, process development, and quality-related computerized systems.
- Collaborate with Facilities and Manufacturing teams to ensure qualification and validation requirements are incorporated into system modifications and upgrades.
- Promote best practices related to data integrity, electronic records management, and regulatory compliance.
- Conduct periodic system reviews to confirm continued validated state and fitness for intended use.
Training & Continuous Improvement- Train business and IT users on compliant operation of GxP systems and supporting procedures.
- Identify opportunities to streamline processes and improve system effectiveness while maintaining regulatory compliance.
- Provide data analysis and actionable insights to support informed business decision-making.
Required Qualifications- Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, or a related discipline.
- 8+ years of IT Business Analysis experience supporting enterprise applications and business processes.
- 5+ years supporting GxP-regulated environments, including GLP and GMP systems.
- Hands-on experience with Computer System Validation (CSV) and Computer Software Assurance (CSA) methodologies.
- Strong knowledge of FDA 21 CFR Part 11, GAMP 5, ALCOA+, and risk-based validation approaches.
- Experience supporting Quality, Manufacturing, Laboratory, Process Development, or Validation business functions.
- Proven ability to gather requirements, analyze business processes, and translate needs into compliant technology solutions.
- Experience supporting audits, inspections, validation documentation, and regulatory inquiries.
- Demonstrated success leading cross-functional initiatives and influencing stakeholders without direct authority.
- Strong analytical, problem-solving, communication, and project management skills.
Preferred Qualifications- Master's degree in Information Systems, Engineering, Life Sciences, or a related field.
- Experience with Quality Management Systems (QMS), document management platforms, LIMS, manufacturing systems, or regulatory affairs applications.
- Experience implementing or supporting cloud-based validated platforms.
- Certification in Business Analysis, Project Management, Quality, or Validation disciplines.
Top Skills- Business Analysis
- Requirements Gathering
- GxP Compliance (GLP/GMP)
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- Quality Management Systems (QMS)
- Project Management
- Regulatory Compliance
- Stakeholder Management
- Data Integrity (ALCOA+)
Experience Level: Senior / Expert (8+ years)
Job Type & LocationThis is a Contract position based out of Lexington, MA.
Pay and BenefitsThe pay range for this position is $60.00 - $75.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace TypeThis is a fully onsite position in Lexington,MA.
Application DeadlineThis position is anticipated to close on Aug 24, 2026.
About TEKsystemsWe're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
About TEKsystems and TEKsystems Global Services We're a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We're a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We're strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We're building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
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