Eikon Therapeutics
Director, IT Computer System Validation & Quality Assurance
Eikon Therapeutics - Millbrae, California, United States, 94030
Work at Eikon Therapeutics
Overview
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Overview
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 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.
Please read the following job description thoroughly to ensure you are the right fit for this role before applying. 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, 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. Apply for this job * indicates a required field First Name * Last Name * Preferred First Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Are you authorized to accept full-time employment in the United States? * Select... If hired, will you now or in the future require sponsorship for employment visa status? * Select... Do you have any relatives or contacts with whom you have personal or social relationships working at Eikon Therapeutics? * Select... Please list the name of your relative(s) or contact(s) who are currently working at Eikon. How did you learn about this opening? By selecting, "I have read and I accept the terms of the NDA", I acknowledge that I have read and agree to be bound by the terms and conditions set forth in this Non-Disclosure Agreement. * Select... By submitting this application, do you certify that the provided information is true and accurate to the best of your knowledge? * Select... Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Eikon Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of DisabilityForm CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
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Please read the following job description thoroughly to ensure you are the right fit for this role before applying. 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, 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. Apply for this job * indicates a required field First Name * Last Name * Preferred First Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Are you authorized to accept full-time employment in the United States? * Select... If hired, will you now or in the future require sponsorship for employment visa status? * Select... Do you have any relatives or contacts with whom you have personal or social relationships working at Eikon Therapeutics? * Select... Please list the name of your relative(s) or contact(s) who are currently working at Eikon. How did you learn about this opening? By selecting, "I have read and I accept the terms of the NDA", I acknowledge that I have read and agree to be bound by the terms and conditions set forth in this Non-Disclosure Agreement. * Select... By submitting this application, do you certify that the provided information is true and accurate to the best of your knowledge? * Select... Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Eikon Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of DisabilityForm CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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