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Senior Director Computer Systems Validation Jobs

Biovire

Director, Validation

Brighton, MI

... Computer Systems Validation. * Play a direct leadership role in site expansion, operational readiness, and regulatory inspection readiness. * Work cross-functionally with senior leaders across ...

Biovire

Director, Validation

Brighton, MI · On-site

$100K - $120K/yr

... and Computer Systems Validation.Play a direct leadership role in site expansion, operational readiness, and regulatory inspection readiness.Work cross-functionally with senior leaders across ...

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Senior Director Computer Systems Validation information

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$72.5K

$143.2K

$212.5K

How much do senior director computer systems validation jobs pay per year?

As of Sep 12, 2026, the average yearly pay for senior director computer systems validation in the United States is $143,206.00, according to ZipRecruiter salary data. Most workers in this role earn between $120,000.00 and $166,000.00 per year, depending on experience, location, and employer.

What is a senior director computer systems validation?

A Senior Director of Computer Systems Validation is a high-level professional responsible for overseeing the validation of computer systems within regulated industries, such as pharmaceuticals or biotechnology. Their role ensures that all computerized systems comply with regulatory standards, like FDA or EMA guidelines, to guarantee data integrity and product quality. They lead teams, develop validation strategies, manage audits, and collaborate with IT, quality, and business departments. This position requires deep knowledge of regulations, validation methodologies, and leadership in managing cross-functional projects.

What are the key skills and qualifications needed to thrive as a senior director computer systems validation?

To thrive as a Senior Director of Computer Systems Validation, you need deep expertise in quality assurance, regulatory compliance (such as FDA 21 CFR Part 11), and a solid background in life sciences or pharmaceuticals, often supported by an advanced degree. Familiarity with validation lifecycle management tools, GAMP guidelines, and experience with enterprise systems like SAP or LIMS is typically required, along with certifications such as PMP or Six Sigma. Exceptional leadership, strategic thinking, and communication skills distinguish top performers in this role. These skills are vital to ensure compliant, efficient implementation of critical computer systems and maintain regulatory readiness in highly regulated industries.

What are the typical challenges faced by a senior director computer systems validation when leading cross-functional teams during large-scale system implementations?

A Senior Director of Computer Systems Validation often encounters challenges such as aligning diverse stakeholder priorities, ensuring regulatory compliance across departments, and managing complex timelines during large-scale system implementations. Coordinating between IT, quality assurance, and business units requires strong communication and negotiation skills, as each group may have different objectives and technical understanding. Additionally, balancing the need for thorough documentation with project deadlines is crucial to maintain both compliance and efficiency. Successfully navigating these challenges can lead to smoother project execution and greater organizational trust in validated systems.

What are popular job titles related to Senior Director Computer Systems Validation jobs?

For Senior Director Computer Systems Validation jobs, the most frequently searched job titles are:

Computer System Validation Engineer

Indianapolis, IN • On-site

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

Contractor

Re-posted 16 days ago

Job description

Job Title: Validation Engineer

Location: Indianapolis / Bloomington, IN (100% Onsite)

Duration: Long term Contract

Interview Mode: Onsite (Local candidates preferred)

Job Summary:

We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation activities, documentation migration, and equipment qualification to ensure compliance with regulatory standards.

Key Responsibilities

  • Lead migration of legacy validation documents into the Kneat digital platform, ensuring accuracy and compliance
  • Perform equipment qualification for lab instruments (pH meters, thermal mixers, peristaltic pumps, nutating mixers, etc.)
  • Execute temperature mapping studies, including work with Ellab systems or similar equipment
  • Support Computer Systems Validation (CSV) activities and documentation
  • Assist Process Engineering teams to ensure project timelines and milestones are met
  • Ensure all validation activities comply with GMP and regulatory requirements
  • Maintain clear, accurate, and compliant documentation

Required Qualifications:

  • Bachelor’s degree in Engineering, Science, or related field
  • 6+ years of experience in Computer Systems Validation (CSV)
  • 4+ years of experience in pharmaceutical manufacturing environment
  • Hands-on experience with equipment qualification and validation
  • Strong knowledge of CSV principles and regulatory compliance
  • Experience working in onsite, fast-paced environments