Job Details

Director, IT Computer System Validation & Quality Assurance

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Overview

As the Director, IT Computer System Validation & Quality Assurance, you will play a pivotal role in ensuring the compliance, reliability, and quality of our computer systems within the biotechnology domain. This position offers a unique opportunity for an experienced professional to lead and make a significant impact on our company's success.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Millbrae, CA office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

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, 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.

Qualifications

• 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. Master's degree is a plus.
• 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.

Benefits and compensation

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

• 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

The expected salary range for this role is $195,000 to $212,800 depending on skills, competency, and the market demand for your expertise.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.