CSV Manager, Quality Systems Technology (QST)

CSV Manager, Quality Systems Technology (QST) Redwood City, California, United States Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. We are looking for a Computer Systems Validation (CSV) Manager who thrives in managing validated systems, compliance initiatives, and system enhancements. This role is a great opportunity for someone who enjoys working at the intersection of technology, quality, and regulatory compliance, ensuring that validated systems supporting GxP activities are reliable, efficient, and compliant! This is a hybrid role typically requiring on-site presence at least 3 days per week. Responsibilities: Drive continuous improvement initiatives for Corcept's Quality Management System (QMS) and support enhancements to validated GxP systems such as Veeva, Argus, SAS and ComplianceWire Collaborate with IT and QA teams to enforce requirements for validated systems Monitor and perform periodic system reviews, identify compliance gaps, and implement corrective actions Prepare for regulatory inspections and support audits by ensuring validated systems meet compliance requirements (GxP, 21 CFR Part 11, and EU Annex 11 requirements) Support Inspection Remediation activities and CAPA closure Evaluate the impact of system updates, patches, and configuration changes, ensuring compliance with GxP regulations and data integrity principles and implement the update Collaborate with cross-functional teams to optimize workflows, reporting capabilities, and system usability to meet business and compliance needs Coordinate vendor release activities and assist in resolving system issues with software and consulting vendors Develop GxP SOPs and support training efforts for personnel on those SOPs and related regulations Preferred Skills, Qualifications and Technical Proficiencies: Thorough understanding of quality systems that support internal GxP activities for pre-clinical, clinical, and commercial products Proficiency in the use of GxP-validated systems such as Veeva (eTMF, Quality, and RIM), SAS, and ComplianceWire Hands-on experience with QMS system implementations or other GXP systems Experience developing GxP SOPs and training personnel regarding those SOPs and the corresponding government regulations Customer-focused and able to prioritize with competing priorities Preferred Education and Experience: 8+ years' experience in the development and maintenance of quality systems in clinical and commercial-stage pharmaceutical companies Deep knowledge of ICH Q10 & GAMP 5, 21 CFR Part 11 and Annex 11 Familiarity with risk-based computer system validation (CSV/CSA) strategies The pay range that the Company reasonably expects to pay for this headquarters-based position is $154,100 - $181,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education. Applicants must be currently authorized to work in the United States on a full-time basis. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link . Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept. Create a Job Alert Interested in building your career at Corcept Therapeutics? Get future opportunities sent straight to your email. Apply for this job indicates a required field First Name * Last 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 Education School Select... Degree Select... Select... Select... Start date year End date month Select... End date year LinkedIn Profile Website Do you currently reside in the Bay Area? * Select... If you do not live in the Bay Area, would you consider relocating to the Bay Area? * Select... Are you authorized to work in the US? * Select... Will you now or in the future require visa sponsorship? Select... If you were referred by a Corcept employee, please indicate the employee name or not applicable * Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification pletion 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 Corcept 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 Disability Form 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 . 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. #J-18808-Ljbffr