Sr Specialist, Quality Systems Technology (QST)

85 Days Old

Sr Specialist, Quality Systems Technology (QST) Join to apply for the Sr Specialist, Quality Systems Technology (QST) role at Corcept Therapeutics . Corcept is leading the way in research and development of cortisol modulators, with over 1,000 proprietary molecules discovered. Since FDA approval of Korlym in 2012 for hypercortisolism, our team continues to explore cortisol modulation for treating serious diseases across various areas including endocrinology, oncology, metabolism, and neurology. We are seeking a Sr Specialist to support and optimize Veeva Quality (QMS & QualityDocs) and ComplianceWire, managing security settings, ensuring compliance, and operational efficiency for processes like deviations, change control, CAPA, and document management. The role involves business administration tasks such as user access management, compliance reporting, training support, and process optimization. Collaboration across functions is essential to enhance system performance, streamline operations, and maintain regulatory compliance. This is a hybrid position requiring on-site presence 3 days per week. Responsibilities: Manage administration of Veeva Quality (QMS and QualityDocs), ensuring system performance, user access, configuration updates, and compliance with regulatory standards. Support the Learning Management System (ComplianceWire) as needed. Support release and maintenance activities for Veeva Quality and ComplianceWire. Maintain system workflows, lifecycles, and security settings to support quality processes such as deviation, change control, CAPA, and document management. Monitor system performance, manage user access, and resolve issues promptly. Identify inefficiencies and recommend improvements to workflows and operations. Provide guidance and support to personnel on using Veeva Quality and ComplianceWire. Serve as the point of contact for onboarding, offboarding, and user access management for other validated systems. Manage and maintain documents for external parties and generate reports to support inspection readiness. Contribute to inspection readiness efforts by supporting logistics and responding to requests. Preferred Skills, Qualifications, and Technical Proficiencies: Advanced proficiency with Electronic Document Management and Learning Management Systems such as Veeva, ComplianceWire, and Zendesk. Experience configuring Veeva Vault applications, including workflows, lifecycles, and security settings; knowledge of validation principles for computerized systems. Effective communication and interpersonal skills to work with both technical and non-technical stakeholders. Ability to respond to inquiries and support questions efficiently. Customer-focused with strong prioritization skills amidst competing priorities. Preferred Education and Experience: BA/BS degree in a scientific, technical, or engineering field. 6+ years of experience in Pharmaceutical Quality Systems or equivalent. The expected pay range for this position is $127,400 - $149,900, with actual offers based on location, skills, experience, and education. Applicants must be authorized to work in the US on a full-time basis. For more information on data privacy, please see our Privacy Notice. Visit our website: https://www.corcept.com/ Corcept is an Equal Opportunity Employer.
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Location:
Redwood City, CA, United States
Job Type:
FullTime
Category:
IT & Technology

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