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 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.
About You
The ideal candidate for this role 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
- 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.
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.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
Top Skills
What We Do
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the interface of biology, engineering and chemistry 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.
By directly measuring the effects of chemical compounds on the behavior of protein molecules in a live cellular environment, Eikon’s landmark assays facilitate the highly sensitive identification of compound-protein interactions that could not be identified through traditional assays, thereby unlocking otherwise intractable classes of proteins as drug targets. Furthermore, the ability to directly visualize protein mechanisms in disease coupled with the extraordinarily high-powered high-content data sets generated by Eikon’s drug-screening technology enable an unprecedented opportunity to quantitatively explore novel biology in the living cell. These insights facilitate creation and application of data-driven hypotheses to the discovery of life-saving therapies.
Eikon is seeking adventurous, passionate and creative team members eager to apply their talents to empower interdisciplinary scientific exploration, inaugurate a radical drug-discovery paradigm, and ultimately create novel medicines. To learn more about open positions, please visit: https://eikontx.com/team#positions
