Manager, Clinical Quality Assurance 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, Biotechnology, Clinical ResearchIndustries

Requirements

BA/BS degree in a relevant field, or equivalent experience
6+ years’ clinical research experience
Understanding of Quality Systems that support GCP quality activities
Experience with advanced Microsoft Office applications (Word, Excel, PowerPoint)
Experience developing GCP processes for the best industry practices and training

Responsibilities

Lead/manage Good Clinical Practice (GCP) audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs)
Serve as a QA representative and support clinical study teams to provide compliance advice
Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents
Manage study-specific Clinical Study Audit Plans (CSAP) compliance for the assigned program by using a risk-based approach for Corcept clinical studies
Review and approve investigational product (IP) temperature excursions to ensure release or rejection of IP on time
Lead continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and excellence
Manage and support inspection readiness activities for GCP
Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigative site inspections, and contract research organization (CRO) inspections
Support GMP, GLP, and PV inspections
Lead clinical non-compliance event investigations and CAPA implementation
Perform quality metric analysis for clinical QA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data
Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies as related to GCPs. Maintain the GCP regulatory surveillance program
Provide cross-training development opportunities to QA team members, and mentor/coach junior QA team members upon request or as an assigned supervisor

Skills

Key technologies and capabilities for this role

GCPClinical AuditsTMFCSRCSAPRisk-Based ApproachSOP ReviewVendor AuditsSite AuditsClinical ComplianceQA

Questions & Answers

Common questions about this position

Is this a remote position or does it require office presence?

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

What are the main responsibilities of the Manager, Clinical Quality Assurance role?

The role involves leading GCP audits, supporting clinical study teams with compliance advice, managing Clinical Study Audit Plans, reviewing investigational product temperature excursions, and supporting inspection readiness activities.

What experience is needed for this position?

The role requires solid clinical research experience, with expertise in Good Clinical Practice (GCP), audits, and clinical quality management systems.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Manager, Clinical Quality Assurance position?

Strong candidates will have solid clinical research experience, knowledge of GCP compliance, audit management skills, and the ability to support clinical study teams and inspection readiness.

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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