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Validation Manager Jobs in Madison, WI (NOW HIRING)

CAI

Validation Engineer

Madison, WI · On-site

$72K - $80K/yr

... Team Management - Plan and coordinate work - Direct small teams in document development and/or execution Qualifications and Experience - Bachelor's degree in a science or engineering field (or ...

CAI

Validation Engineer

Madison, WI · On-site

$72K - $80K/yr

... Team Management - Plan and coordinate work - Direct small teams in document development and/or execution Qualifications and Experience - Bachelor's degree in a science or engineering field (or ...

CAI

Senior Validation Engineer

Madison, WI · On-site

$87K - $94K/yr

... Management - Support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities - Coordinate with project contractors and equipment vendors to execute required ...

CAI

Senior Validation Engineer

Madison, WI

$87K - $94K/yr

... Management - Support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities - Coordinate with project contractors and equipment vendors to execute required ...

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Validation Manager information

See Madison, WI salary details

$47.9K

$106.2K

$161.7K

How much do validation manager jobs pay per year?

As of Aug 24, 2026, the average yearly pay for validation manager in Madison, WI is $106,219.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,100.00 and $133,000.00 per year, depending on experience, location, and employer.

What is a validation manager?

A validation manager works in a manufacturing plant and oversees the proper operation of machinery and equipment. Your job duties include developing operational plans for the entire facility, identifying areas of process improvement, and scheduling periodic auditing reviews of the facility. The qualifications needed for a career as a validation manager include a bachelor’s degree in business, organizational theory, quality control, or a related field. You also need strong communication and computer skills and experience in a management position.

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

To thrive as a Validation Manager, you need a strong background in quality assurance, regulatory compliance (such as FDA or EMA guidelines), and validation principles, usually supported by a degree in life sciences or engineering. Familiarity with validation protocols, risk management tools, and systems like GMP documentation platforms is essential. Leadership, attention to detail, and effective communication are crucial soft skills for managing teams and coordinating cross-functional projects. These skills and qualities ensure that products and processes consistently meet regulatory standards, reducing risks and ensuring compliance.

How does a validation manager typically collaborate with other departments during project execution?

Validation Managers frequently work cross-functionally with quality assurance, manufacturing, engineering, and regulatory teams to ensure all systems and processes meet required standards. Effective collaboration involves coordinating validation protocols, sharing critical documentation, and communicating status updates to keep projects on track. A Validation Manager often leads meetings to align stakeholders, addresses compliance concerns, and resolves issues swiftly to prevent delays. Building strong relationships across departments is essential for smooth validation processes and successful project outcomes.

What is the difference between Validation Manager vs Quality Assurance Specialist?

AspectValidation ManagerQuality Assurance Specialist
CertificationsGxP, ISO, or industry-specific validation certificationsISO, Six Sigma, or QA-related certifications
Work EnvironmentRegulated industries like pharmaceuticals, biotech, or medical devicesManufacturing, software, or service industries
Primary FocusEnsuring validation processes for equipment, systems, and processes meet standardsMonitoring and improving overall quality processes and compliance

The Validation Manager primarily oversees validation activities to ensure compliance with industry standards, focusing on equipment and process validation. In contrast, the Quality Assurance Specialist concentrates on maintaining overall quality standards across products and services. Both roles are essential for compliance but differ in scope and responsibilities.

More about Validation Manager jobs

What are the most commonly searched types of Validation jobs in Madison, WI?

The most popular types of Validation jobs in Madison, WI are:

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For Validation Manager jobs in Madison, WI, the most frequently searched job titles are:

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Validation Manager jobs near you
Infographic showing various Validation Manager job openings in Madison, WI as of August 2026, with employment types broken down into 84% Full Time, 13% Part Time, and 3% Contract. Highlights an 83% Physical, 2% Hybrid, and 15% Remote job distribution, with an average salary of $106,219 per year, or $51.1 per hour.

Senior Manager, GxP Systems & Validation

Verona, WI • On-site

Arrowhead Pharmaceuticals
Pharmaceutical and Medicine Manufacturing • 201 - 500 employees
Learn more about Arrowhead Pharmaceuticalsexternal

Full-time

Re-posted 14 days ago

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Senior Manager GxP Systems & Validation provides strategic and operational leadership for GxP-regulated computerized systems across their full lifecycle. This role is accountable for governance, validation strategy, inspection readiness, and compliant system administration, ensuring alignment with global regulatory requirements (FDA, EMA, MHRA, ICH) and evolving industry standards (GAMP 5, CSA).
This leader serves as a key partner to Manufacturing, Quality, CMC, CSA and Compliance, GLP Operations, and external vendors, driving scalable compliance frameworks while enabling business agility. The role combines system ownership and administration, validation project management, and organizational oversight to ensure enterprise-wide data integrity and computerized system compliance.
Responsibilities
Strategic Leadership & Governance
  • Maintain governance frameworks for GxP computerized systems
  • Define validation strategies aligned with GAMP 5 and CSA principles
  • Support modernization initiatives (e.g., SaaS adoption, cloud validation, CSA transition)
  • Serve as system owner and system administrator for critical GxP platforms
  • Maintain validation and system lifecycle policies and standards
  • Participates in continuous improvement of validation methodologies, templates, and risk-based approaches
  • Provide compliance guidance to executive leadership and functional heads

System Lifecycle Oversight
  • Oversee administration and compliant operation of GxP systems (Laboratory systems, LIMS, MES, EDMS, enterprise SaaS platforms)
  • Ensure systems remain validated, secure, and audit-ready throughout implementation, upgrades, and decommissioning
  • Approve system configurations, changes, and access governance frameworks
  • Ensure robust data integrity controls in accordance with ALCOA+ principles
  • Monitor system performance, audit trails, cybersecurity controls, and vendor compliance

Validation Program Leadership
  • Lead enterprise validation initiatives across multiple concurrent projects
  • Oversee development and approval of validation deliverables (URS, Risk Assessments, IQ/OQ/PQ, Traceability, Summary Reports)
  • Ensure appropriate application of risk-based validation and CSA methodologies
  • Manage validation master planning and resource allocation
  • Provide oversight of regression testing and revalidation strategies
  • Ensure validation documentation supports global inspection readiness
  • Act as SME during regulatory inspections and internal audits
  • Oversee remediation efforts related to audit findings, deviations, and CAPAs
  • Maintain awareness of evolving global regulatory expectations

Project & Vendor Management
  • Lead cross-functional teams across CMC, Quality, IS&I, Manufacturing, Engineering, GLP Operations, and external partners
  • Oversee third-party vendors and validation consultants
  • Manage budgets, timelines, risks, and resource planning for validation programs
  • Drive issue resolution and escalation management
  • Ensure vendor deliverables meet compliance and quality standards

People & Organizational Development
  • Lead, mentor, and develop validation and system administration staff
  • Establish performance expectations and competency development plans
  • Build scalable team capabilities to support business growth

Requirements
  • Bachelor's degree in Life Sciences, Engineering, IT, or related discipline (advanced degree preferred)
  • 8+ years of experience in GxP computerized systems and validation
  • 3+ years in a leadership or program management role
  • Deep expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, and global data integrity requirements
  • Demonstrated experience leading complex, enterprise-level system implementations
  • Strong understanding of change control, deviation management, CAPA, and quality systems
  • Proven ability to influence senior stakeholders and drive cross-functional alignment

Preferred
  • PMP or equivalent project management certification
  • GAMP, ITIL, or related compliance certification
  • Experience leading CSA transformation initiatives
  • Extensive experience related to administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson)
  • Pharmaceutical or CRO experience
  • Prior regulatory inspection leadership experience
  • Risk-based decision making
  • Continuous improvement mindset

Wisconsin pay range
$145,000-$165,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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