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Computer System Validation Manager Jobs in Massachusetts

Avantor, Inc.

Quality Validation Engineer

Devens, MA · On-site

Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Project management skills: planning, scheduling, stakeholder management, risk communication, and ...

Avantor Inc.

Quality Validation Engineer

Devens, MA · Hybrid

Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Project management skills: planning, scheduling, stakeholder management, risk communication, and ...

AMRESCO

Quality Validation Engineer

Devens, MA · Hybrid

Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related ... Project management skills: planning, scheduling, stakeholder management, risk communication, and ...

Moderna, Inc.

Sr. Engineer, GxP Systems

Norwood, MA · On-site

$121.60K - $194.50K/yr

Manage system change controls and configuration updates and validate changes, ensuring that ... Conduct Computer System Validation (CSV) activities by developing and executing SDLC qualification ...

Cipla

$76K - $103K/yr

... management tools (e.g., MS Project, Primavera). • Experience with SAP systems for engineering and financial operations. • PMP certification is a plus. • Experience with audit preparation ...

Cipla

Validation Supervisor

Fall River, MA · On-site

$76K - $103K/yr

... management tools (e.g., MS Project, Primavera). • Experience with SAP systems for engineering and financial operations. • PMP certification is a plus. • Experience with audit preparation ...

Cipla

Validation Supervisor

Fall River, MA

$76K - $103K/yr

Project Lead - Validation (Supervisor) FLSA Classification : Full-Time, Exempt/Salary Professional ... management tools (e.g., MS Project, Primavera). Experience with SAP systems for engineering and ...

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$51.9K

$115.1K

$175.3K

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

As of May 31, 2026, the average yearly pay for computer system validation manager in Massachusetts is $115,126.00, according to ZipRecruiter salary data. Most workers in this role earn between $81,400.00 and $144,200.00 per year, depending on experience, location, and employer.

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 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 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 the most commonly searched types of Computer System Validation jobs in Massachusetts? The most popular types of Computer System Validation jobs in Massachusetts are:
What are popular job titles related to Computer System Validation Manager jobs in Massachusetts? For Computer System Validation Manager jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Massachusetts look for? The top searched job categories for Computer System Validation Manager jobs in Massachusetts are:
What cities in Massachusetts are hiring for Computer System Validation Manager jobs? Cities in Massachusetts with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you

Senior Manager, Quality Systems

Azurity Pharmaceuticals - US

Woburn, MA • Hybrid

Other

Posted 14 days ago

Job description

Brief team/department description:

Job Type: Full-Time

The Manager, Documentation Management plays a leadership role in sustaining a robust and inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment. This position is responsible for ensuring the integrity, compliance, and continuous improvement of controlled documentation and electronic quality systems, with a strong focus on adherence to GxP and regulatory requirements such as 21 CFR Part 11 and EU Annex 11.

Principle Responsibilities:

  • Lead the development, implementation, and continuous improvement of a compliant, inspection-ready Quality Management System (QMS) in accordance with industry regulations and internal standards.
  • Oversee the validation, integrity, and lifecycle compliance of electronic quality systems, including enterprise-wide document management platforms.
  • Manage the Documentation Management System, ensuring efficient control, authorship, review, approval, and periodic revision of all controlled documents (e.g., SOPs, policies, work instructions) in alignment with lifecycle and regulatory requirements.
  • Direct document lifecycle activities, ensuring timely execution and alignment with GxP standards and applicable regulatory frameworks.
  • Develop and lead GxP training strategies and programs to ensure that functional teams maintain a high level of quality awareness and compliance readiness.
  • Drive cross-functional continuous improvement initiatives aimed at optimizing quality system performance and documentation processes.
  • Lead the planning, oversight, and execution of the Computer System Validation (CSV) program to ensure compliance with 21 CFR Part 11, EU Annex 11, and internal validation requirements.
  • Serve as a point of contact for internal and external audits and regulatory inspections, ensuring documentation systems are readily accessible, compliant, and defensible.

Qualifications and Education Requirements:

  • Bachelor's degree in Life Sciences, Pharmacy, Quality, or a related field (advanced degree preferred).
  • 5-7 years of progressive experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotech industry.
  • Strong working knowledge of GxP principles, 21 CFR Part 11, EU Annex 11, and other applicable regulatory standards.
  • Proven experience managing electronic Document Management Systems and executing Computer System Validation (CSV) activities.
  • Demonstrated leadership, project management, and cross-functional collaboration skills.
  • Exceptional attention to detail, organizational capability, and ability to manage multiple priorities in a fast-paced, regulated environment.

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