CSV Manager, Quality Systems Technology (QST) at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

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

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

Skills

Key technologies and capabilities for this role

CSVComputer Systems ValidationGxP21 CFR Part 11EU Annex 11VeevaArgusSASComplianceWireQMSQuality Management SystemCAPARegulatory Compliance

Questions & Answers

Common questions about this position

Is this a remote or hybrid role?

This is a hybrid role typically requiring on-site presence at least 3 days per week.

What systems experience is preferred for this role?

Proficiency in GxP-validated systems such as Veeva (eTMF, Quality, and RIM), SAS, and ComplianceWire is required, along with hands-on experience with QMS system implementations.

What key skills are needed for the CSV Manager position?

A thorough understanding of quality systems supporting GxP activities, experience developing GxP SOPs, and training personnel on SOPs and regulations are essential.

What is the salary range for this position?

This information is not specified in the job description.

What makes a strong candidate for this CSV Manager role?

Candidates who thrive at the intersection of technology, quality, and regulatory compliance, with experience managing validated GxP systems like Veeva and SAS, and a strong grasp of GxP regulations will stand out.

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

Teva's antitrust lawsuit could lead to legal expenses and market share loss.

Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.

Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

Differentiation

Corcept specializes in cortisol modulation, a niche with few direct competitors.

Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.

Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

Upsides

Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.

Advancements in drug delivery systems could enhance Corcept's product efficacy.

The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

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