Director, IT Computer System Validation & Quality Assurance

Director, IT Computer System Validation & Quality Assurance

Millbrae, CA

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.

Position

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 requires a minimum of 3 days a week 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 and collaboration.

About You

The ideal candidate should possess experience in computer system validation and quality assurance within the biotech or pharmaceutical industry and demonstrate in-depth knowledge of regulatory requirements such as FDA and GxP pertaining to computer system validation and quality assurance. Proficiency in writing validation documentation, along with exceptional analytical and problem-solving skills, is essential. Strong leadership and communication skills are also critical for providing leadership to the Quality Assurance team and ensuring compliance with industry standards and regulatory demands in computer system validation and quality assurance.

What You’ll Do

• 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.

Qualifications

• Postgraduate degree with 10+ years of experience or a bachelor’s degree with 12+ years 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…