New · posted Oct 15
Corcept Therapeutics · Pharmaceuticals
Senior Manager, Clinical Quality Assurance
- Redwood City, CA
- Hybrid
- Full-time
- Manager
Open until filled
The role
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.
The Senior Manager of Clinical Quality Assurance (CQA) is a key member of the CQA team and will perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies sponsored by Corcept.
This is a hybrid role typically requiring on-site presence at least 3 days per week.
What you need
Preferred Education and Experiencenice to have
- BS/BA (science or related field) or equivalent experience
- 8+ years clinical research experience, 2+ years CQA experience preferred
Applicants must be currently authorized to work in the United States on a full-time basis.
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.
Preferred Skills, Qualifications and Technical Proficienciesnice to have
- Thorough understanding of Quality Systems that support GCP activities
- Experience developing GCP processes for the best industry practices
- Experience leading complex quality investigations, root cause analysis and corrective and preventative actions
What you'll do
- Develop/manage study audit plans ensuring compliance oversight for assigned studies by using a risk-based approach
- Lead/manage Good Clinical Practice (GCP) audits, including clinical investigator site, Trial Master File (TMF), and applicable study documents, including Clinical Study Reports (CSRs)
- Support clinical service provider and development internal process audits
- Assess changes to qualified service provider services and their impact to ongoing clinical studies
- Serve as a CQA Lead representative on assigned clinical studies and provide compliance support and oversight throughout the study lifecycle
- Support clinical study teams in risk management activities including the identification of critical to quality (CtQ) factors for each clinical study, implementing risk proportionate study activities in accordance with CtQs and the monitoring of identified risks to the CtQs
- Review clinical study documents and plans and provide CQA compliance review and approval of clinical development SOPs
- Manage and support GCP inspection readiness activities for assigned studies in alignment with study milestones
- Support clinical inspections conducted by regulatory agencies, including sponsor, clinical investigator site, and service provider inspections
- Lead critical investigations, to ensure regulatory reporting compliance
- Support, review and approve clinical non-compliance records (deviations and CAPA)
- Maintain a contemporary knowledge of agency and industry trends, standards, regulations and methodologies related to GCP
- Provide cross-training development opportunities to CQA team, and mentor/coach junior QA team members
- Some travel required
Pay
$173,430 – $204,030 a year
Employer providedThe pay range that the Company reasonably expects to pay for this headquarters-based position is $173,430 – $204,030; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Where you'll work
Redwood City, CAHybridOpen in Maps (opens in a new tab)
More jobs in Redwood City, CAEqual opportunity, accessibility and legal noticesCorcept Therapeutics's statements, word for word
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.
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% above the US median for Clinical Quality & Safety roles at this level.
This roleEmployer provided
Manager roles in the US8 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $173,430 | — | $204,030 |
| All US (middle half) | $165,125 | $174,250 | $177,625 |
This role: Corcept Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Quality & Safety roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Quality & Safety
The general path across 34 open Clinical Quality & Safety roles on Regulatory Jobs, with the titles they carry most. Not Corcept Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance13
- Collaboration and leadership7
- Investigations and CAPA5
- Documentation and SOPs3
- Quality systems and risk2
- Lab testing and methods1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Corcept Therapeutics on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 1
- Locations
By discipline
- Quality2 40%
- Compliance & Safety2 40%
- Regulatory1 20%
By level
- Manager3 60%
- Director1 20%
- Senior & Principal1 20%
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Senior Manager, Clinical Quality Assurance at Corcept Therapeutics
Open until filled. $173K–$204K a year, employer provided.