Manager, Computer Systems Validation (CSV)

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . The Manager, Computer Systems Validation (CSV) will be a core member of the Quality Systems Technology team and responsible for the implementation, management, ongoing support and review of Corcept’s internal GXP validated systems. This individual will ensure IT Quality and Risk Management standards are defined, understood, designed into work activity, and achieved. This position will manage day-to-day operations for IT Compliance and Risk Management, working closely with key stakeholders from business teams, particularly QA, heavily guiding business teams on validation principles and requirements throughout the system lifecycle. This role will ensure compliance risks are identified, mitigated, and managed appropriately. Responsibilities: Provide assessment/review/oversight for Enterprise / GXP computer systems validation (focus on Pharmaceutical Systems) Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies Ensure compliance and the validated state of all GXP systems Provide validation guidance on data migration activities as needed Provide IT assessment and approval for GXP computer system changes Develop and support testing of proposed changes in system development environments Experience in authoring and managing documents such as change control, Risk Assessments, Validation Plans, User Requirements Specifications, Functional Specifications, qualification protocols (IQ/OQ/PQ), Traceability Matrix, system procedures, deviations and CAPAs Coordinate and support vendor support release activities Support and provide guidance to cross-functional groups with GXP system implementation projects and ongoing validation needs including system enhancements, releases and revalidation Responsible to manage external CSV consultants in CSV projects Responsible as interface between IT and QA Preferred Education and Experience: 8+ years’ experience in QA or Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharma/biotech environment Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 210, 211& 11, Annex 11, GAMP5, ICH Q9, Data Integrity, CSA Skills, Qualifications, or Technical Proficiencies: Thorough understanding of validation/qualification and concepts as it applies to pharmaceutical quality systems Excellent communication skills with the ability to effectively communicate across organizational levels and functions Proficiency with Veeva QualityDocs / QMS and ComplianceWire Experience with CTMS and Regulatory systems Ability to manage external software and consultant vendors The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,600 – $189,000; 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 th…