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Computer System Validation Manager Jobs in Boston, MA

Sebela Pharma

CQV/Validation Engineer

Holbrook, MA · On-site

$33 - $43/hr

Support equipment, utility, facility, process, cleaning, and computerized system validation ... Auto CAD experience preferred. * Flexible to work overtime (paid) as needed. Pay Range: $33.00 ...

ClifyX

ELN Developer

Boston, MA · On-site

... versed with computer system validation • Experience in handling both BAU activities and minor enhancements preferred Qualifications : Required : • Looking for people with Biology / Bio ...

Emvia, Inc.

Automation Validation Lead

Andover, MA · On-site +1

... Manager. Key Responsibilities: Finalize the Automation Validation Plan Work with a team of ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...

Avacone

Onsite Lab IT Support Specialist

Cambridge, MA · On-site

Follow Computer System Validation (CSV), change-control, incident-management, and documentation processes. * Maintain accurate records of incidents, configurations, troubleshooting activities ...

New

Avacone

Onsite Lab IT Support Specialist

Cambridge, MA · On-site

Follow Computer System Validation (CSV), change-control, incident-management, and documentation processes. * Maintain accurate records of incidents, configurations, troubleshooting activities ...

New

Genezen

Sr. System Administrator

Lexington, MA · On-site

$140K - $165K/yr

Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...

Genezen

Sr. System Administrator

Lexington, MA · On-site

$96K - $130K/yr

Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...

Genezen

Sr. System Administrator

Lexington, MA · On-site

$96K - $130K/yr

Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...

GSK

Lab Robotics Manager

Cambridge, MA · On-site

... Manager will act as key enabler for the automation of the Scientific Area, Vx CL&AP, and DDS ... Quality, Computer System Validation, Tech, Procurement and the R&D scientific platforms to ...

GlaxoSmithKline

Lab Robotics Manager

Cambridge, MA · On-site

... Manager will act as key enabler for the automation of the Scientific Area, Vx CL&AP, and DDS ... Quality, Computer System Validation, Tech, Procurement and the R&D scientific platforms to ...

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Showing results 41-60

All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Boston, MA

Computer System Validation Manager information

See Boston, MA salary details

$51.6K

$114.5K

$174.4K

How much do computer system validation manager jobs pay per year?

As of Sep 7, 2026, the average yearly pay for computer system validation manager in Boston, MA is $114,523.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,900.00 and $143,400.00 per year, depending on experience, location, and employer.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What are the key skills and qualifications needed to thrive as a computer system validation manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are popular job titles related to Computer System Validation Manager jobs in Boston, MA?

For Computer System Validation Manager jobs in Boston, MA, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Manager jobs in Boston, MA look for?

The top searched job categories for Computer System Validation Manager jobs in Boston, MA are:

What cities near Boston, MA are hiring for Computer System Validation Manager jobs?

Cities near Boston, MA with the most Computer System Validation Manager job openings:

Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Boston, MA as of August 2026, with employment types broken down into 84% Full Time, 15% Part Time, and 1% Contract. Highlights an 79% Physical, 3% Hybrid, and 18% Remote job distribution, with an average salary of $114,523 per year, or $55.1 per hour.

Sr Director, QA- GxP Systems

Candel Therapeutics, Inc.

Needham, MA • On-site

$258.33 - $280/hr

Other

Re-posted 25 days ago

Job description

Location: Hybrid (3 days/week in Needham, MA; 2 days remote)

Type: Individual contributor (no direct reports)

Salary: $258,333 - $280,000 + 25% bonus

Position Summary

This role is a highly visible, senior quality systems professional who thrives in fast‑paced, resourceful environments. The hire will report directly to the SVP of Quality and act as a strategic partner across departments, independently owning vendor oversight, computer system validation, and overall GxP system effectiveness. The incumbent is a builder of systems, processes, and trust.

What You’ll Own
  • Quality Operations Leadership: Manage the end‑to‑end lifecycle of GxP systems across QA, Clinical Ops, CMC, and Research, ensuring full compliance with 21 CFR Part 11 and modern industry standards.
  • Vendor Oversight & Auditing: Lead qualification, risk assessment, and ongoing oversight of a diverse ecosystem of internal and external vendors—ranging from eQMS and EDMS to training systems, supply chain tools, and cloud‑based clinical applications.
  • System Validation & Governance: Own all CSV (computer system validation) activities, including SOP development, vendor questionnaires, test scripts, reports, periodic reviews, and revalidations. Maintain inspection‑readiness at all times.
  • Cross‑functional Enablement: Support scientific teams (PD, analytical, R&D) by ensuring vendor and data integrity for BLA‑enabling work. Bridge clinical and commercial quality expectations through practical systems thinking.
  • Training & Continuous Improvement: Deliver GxP systems training and drive continuous improvement initiatives, trend analysis, and knowledge management across the organization.
  • Documentation & Record Management: Oversee document bundling, review, and archiving for key deliverables such as batch records, stability studies, and QA releases. Ensure audit‑ready files and streamlined workflows.
What You Bring
  • Bachelor’s degree in Life Sciences or a related technical field.
  • 10+ years of experience in biotech/pharma Quality Assurance, with direct ownership of GxP systems and a proven track record managing audits, vendors, and validations.
  • Expertise with eQMS, EDMS, training systems, and other regulated platforms; familiarity with stability, batch records, and clinical supply workflows.
  • Background in clinical‑stage or hybrid clinical/commercial environments, with a hands‑on approach to QA operations and system management.
  • Strong understanding of ICH, FDA, and Part 11 requirements, and their application to cloud‑based, outsourced, and evolving environments.
  • Experience in cross‑functional quality enablement, supporting teams such as PD, Analytical, and Clinical in system compliance.
  • Critical thinker who can navigate ambiguity, prioritize work, and maintain momentum without daily direction.

NOTE: All applicants must be authorized to work in the US and do not require sponsorship. Unfortunately, we are unable to provide sponsorship of any kind at this time.

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