CSV Manager, Quality Systems Technology
18 hours ago
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
- 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
- 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.
Please visit our website at: https://www.corcept.com/
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.
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