Eikon Therapeutics · 1 week ago
Director, IT Computer System Validation & Quality Assurance
Millbrae, CA
Full-time
Onsite
Director/Executive
$195K/yr - $213K/yr
10+ years expEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology to discover novel treatments for life-threatening diseases. The Director, IT Computer System Validation & Quality Assurance will ensure the compliance, reliability, and quality of computer systems, leading the Quality Assurance team and collaborating with various departments to meet regulatory standards.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Define and drive the global strategy for CSV and software QA aligned with regulatory standards and company goals
Establish governance for validation lifecycle management, including system risk assessments, validation planning, testing, and periodic reviews
Collaborate with IT, Clinical, Pharmacovigilance, Biostatistics, and Regulatory teams to ensure compliant and robust software systems
Own and evolve the organization's CSV framework across GxP and non-GxP systems
Ensure that validation activities meet regulatory and business requirements for systems like Veeva Vaults, QMS, Safety systems and custom applications
Develop and execute strategies for the validation of computer systems, ensuring compliance with industry standards, regulatory requirements, and company policies
Establish and maintain validation protocols, including test scripts, plans, and reports
Provide leadership and direction to the Software Quality Assurance team, fostering a culture of quality excellence
Collaborate with cross-functional teams to ensure that computer systems meet quality standards and perform efficiently
Create, review, and maintain comprehensive documentation related to computer system validation activities
Prepare validation reports and documentation for regulatory submissions and audits
Design and oversee the execution of test cases to verify the functionality and performance of computer systems
Identify and document deviations, issues, and discrepancies encountered during testing
Identify opportunities for process optimization and efficiency improvements in computer system validation and quality assurance
Develop and deliver training programs for relevant stakeholders
Stay current with industry regulations and standards related to computer system validation and quality assurance
Ensure audit readiness for internal and external inspections (e.g., FDA, EMA, etc.)
Assist in regulatory inspections and audits as required
Qualification
Required
Post Graduate degree with 10+ years of experience or a bachelor's degree with 12+ years of experience in Computer Science, Information Technology, Engineering, or a related field
A minimum of 10+ years of experience in computer system validation and quality assurance within the biotech or pharmaceutical industry
In-depth knowledge of regulatory requirements (FDA, GxP, GAMP, etc.) related to computer system validation and quality assurance
Strong experience with CSV in GxP environments, including risk-based validation approaches
Experience working with Veeva Development Cloud Vaults and Commercial solutions
Familiarity with software development methodologies (Agile, Waterfall, V-model)
Proficiency in writing validation documentation, including protocols, reports, and procedures
Exceptional analytical and problem-solving skills with meticulous attention to detail
Strong leadership and communication skills, with the ability to collaborate effectively with cross-functional teams
Preferred
Master's degree is a plus
Benefits
401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
Company
Eikon Therapeutics
Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.
201-500 employees
H1B Sponsorship
Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (17)
2023 (7)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M
Leadership Team
Roger Perlmutter
Chairman, President, and CEO
Michael Klobuchar
Chief Operating Officer
Recent News
General Catalyst
2025-12-26
2025-12-02
Company data provided by crunchbase