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Gxp Systems Jobs (NOW HIRING)

IT Specialist III, GMP Systems

Redmond, WA ยท On-site

$115K - $126.50K/yr

Follow Computerized Systems Validation (CSV) process to build out and qualify/validate GxP systems. * Directly responsible for deployment, as well as authoring IT validation documents such as System ...

Follow Computerized Systems Validation (CSV) process to build out and qualify/validate GxP systems. * Directly responsible for deployment, as well as authoring IT validation documents such as System ...

Follow Computerized Systems Validation (CSV) process to build out and qualify/validate GxP systems. * Directly responsible for deployment, as well as authoring IT validation documents such as System ...

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Gxp Systems information

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$46K

$102.1K

$153K

How much do gxp systems jobs pay per year?

As of May 29, 2026, the average yearly pay for gxp systems in the United States is $102,067.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,000.00 and $125,000.00 per year, depending on experience, location, and employer.

What is a GxP Systems job?

A GxP Systems job involves managing, implementing, and maintaining computerized systems that comply with regulatory standards like FDA, EMA, and other industry guidelines. These systems support Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) in industries such as pharmaceuticals and biotechnology. Responsibilities typically include validation, documentation, compliance assessments, and ensuring data integrity. The role requires knowledge of regulatory requirements, IT systems, and quality assurance principles.

What are the key skills and qualifications needed to thrive in the Gxp Systems position, and why are they important?

To thrive in a GxP Systems role, strong knowledge of GxP (Good Practice) regulations, computer system validation (CSV), and IT compliance are essential, usually supported by a degree in a scientific or technical field. Familiarity with quality management systems (QMS), 21 CFR Part 11, audit processes, and common validation and documentation tools is typically required, and certifications such as PMP or GAMP can be advantageous. Excellent problem-solving, attention to detail, and communication skills help professionals manage highly regulated projects and collaborate across departments. These capabilities are vital to ensure technology systems meet regulatory standards, reduce compliance risks, and maintain data integrity in regulated environments.

What are the main responsibilities of someone working in GxP Systems?

Professionals in GxP Systems are responsible for implementing, validating, and maintaining computerized systems used in regulated environments, ensuring these systems comply with industry regulations such as FDA, EMA, or ICH guidelines. Their daily tasks typically include managing system validation projects, performing risk assessments, handling documentation, supporting audits, and collaborating with IT, Quality Assurance, and business users. The role also involves troubleshooting issues, keeping up with regulatory updates, and providing user training. Given the critical nature of compliance in life sciences and healthcare, attention to detail and cross-functional teamwork are crucial for success.
What cities are hiring for Gxp Systems jobs? Cities with the most Gxp Systems job openings:
What are the most commonly searched types of Gxp Systems jobs? The most popular types of Gxp Systems jobs are:
What states have the most Gxp Systems jobs? States with the most job openings for Gxp Systems jobs include:
Infographic showing various Gxp Systems job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $102,067 per year, or $49.1 per hour.

Senior Director, Quality Systems

Kailera Therapeutics, Inc.

Waltham, MA โ€ข On-site

Other

Posted 2 days ago


Job description

What You'll Do:

The Senior Director, Quality Systems is a high-impact leadership role responsible for the architecture, implementation, and continuous improvement of our Enterprise Quality Management System (eQMS). You will report to the Vice President, Quality and will serve as the primary architect of our quality framework, ensuring our global operations remain compliant with GxP standards while maintaining the agility required of a growing biotech.

Required location: Waltham, MAย (hub-based, onsite 3-4 days per week)

Responsibilities:

  • Define and execute the long-term vision for the Quality Management System (QMS) to support global clinical development and future commercialization
  • Provide Quality oversight for GxP systems change controls. Support validation planning, execution, approvals
  • Act as the Business Owner for Veeva QualityVault. Lead the optimization of modules including Document Control, Training, Deviations, CAPA, and Change Control
  • Establish and lead Quality Management Reviews (QMR). Develop and report on Key Quality Indicators (KQIs) and metrics to senior leadership to drive proactive risk management
  • Ensure the QMS meets global regulatory requirements (FDA 21 CFR Parts 11, 210, 211, and 820; ICH E6; EudraLex Volume 4)
  • Lead the QMS strategy for inspection readiness. Serve as a key interface during regulatory inspections (FDA, EMA, etc.) and oversee the internal and vendor audit programs
  • Champion a culture of Quality. Streamline complex workflows to reduce cycle times for document approvals and deviation closures without compromising compliance
  • Build and mentor a high-performing team of Quality professionals, fostering a collaborative environment that balances technical rigor with pragmatic problem-solving

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Required Qualifications:

  • 12+ years of experience in Quality Assurance within the Biotech/Pharmaceutical industry, with at least 5 years in a senior leadership capacity
  • Direct experience implementing or managing Veeva QualityVault is mandatory. You should be proficient in configuring workflows and leveraging the platform for data-driven decision-making
  • Proven track record in mid-sized companies navigating the transition from early-phase clinical trials to late-stage pivotal studies
  • Deep knowledge of global GxP regulations and experience participating in (or leading) successful regulatory inspections
  • Exceptional ability to translate complex quality requirements into actionable business strategies for non-quality stakeholders

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Education:

  • Bachelor's degree required, scientific or engineering discipline preferred
  • Advanced degree preferred