Senior Specialist, Quality Systems Technology

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.

Join our dynamic team as a Sr. Specialist to support and optimize Veeva Quality (QMS & QualityDocs) and ComplianceWire at Corcept In this role, you'll manage security settings, while ensuring compliance and operational efficiency for key quality processes like deviations, change control, CAPA, and document management.

You will also handle business administration tasks, including user access management, compliance reporting, training support, and process optimization. This role requires cross-functional collaboration to enhance system performance, streamline operations, and maintain regulatory compliance. Make an impact by driving seamless system operations in a fast-paced environment. This is a hybrid role typically requiring on-site presence at least 3 days per week.

Responsibilities:

• Manage the administration of Veeva Quality (QMS and QualityDocs), ensuring system performance, user access, configuration updates, and compliance with regulatory standards. Provide support for the Learning Management System (ComplianceWire) as needed
• Support the release and maintenance of Veeva Quality (QMS and QualityDocs) and ComplianceWire activities
• 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 address issues promptly to maintain system integrity and efficiency
• Identify inefficiencies and recommend improvements to document workflows and operation processes
• Provide basic guidance and support to Corcept personnel on using Veeva Quality and ComplianceWire
• Serve as the point of contact for onboarding and offboarding processes and user access management for other Quality validated systems
• Manage and maintain documents for external parties. Generate reports to support inspection readiness and users
• Contribute to inspection readiness efforts by supporting logistics and responding to requests

Preferred Skills, Qualifications and Technical Proficiencies:

• Advanced proficiency and hands-on experience with Electronic Document Management and Learning Management Systems such as Veeva, ComplianceWire and Zendesk
• Proficiency in configuring Veeva Vault applications, including workflows, lifecycles, and security settings. Knowledge of the principles of validation as applied to computerized systems and processes
• Effective communication and interpersonal skills, capable of working with both technical and non-technical stakeholders
• Ability to respond to email inquiries and user support questions
• Customer-focused and able to prioritize with competing priorities with internal stakeholders

Preferred Education and Experience:

• BA/BS degree in a scientific/technical/engineering field
• 6+ years experience in Pharmaceutical Quality Systems or equivalent

The pay range that the Company reasonably expects to pay for this headquarters-based position is $127,400 - $149,900; 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.

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Corcept is an Equal Opportunity Employer
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