New · posted Oct 15
Corcept Therapeutics · Pharmaceuticals
Associate Director, Clinical Quality Assurance
- Redwood City, CA
- Hybrid
- Full-time
- Director
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 Associate Director of Clinical Quality Assurance (CQA) is a lead member of the CQA team and will lead and perform day-to-day CQA operations and compliance activities at the clinical program level 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
- BA/BS degree in biological sciences, pharmacy, related field or equivalent experience is required
- 10+ years’ experience development and maintenance of clinical quality systems and performing GCP audits for clinical stage pharmaceutical companies
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
- Ability to prepare for and defend regulatory agency inspections
- Ability to perform GCP audits is required
- Experience in developing GCP SOPs and training personnel regarding those SOPs and the government regulations to which they apply
- Thorough understanding of the quality systems that support internal GCP activities for clinical documentation and clinical trials
- Excellence in basic Microsoft Office applications (Word, Excel, PowerPoint) is required
What you'll do
- Lead Clinical Quality Assurance activities and oversee assigned CQA team members to ensure compliance oversight of all clinical studies within a clinical development program
- Support the management and growth of the CQA team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team’s capabilities meet Corcept’s current and future needs
- 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 clinical 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
- Evaluate new processes and initiatives impacting clinical programs/studies as CQA representative and support the implementation as needed
- 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 clinical program/studies in alignment with study milestones
- Support regulatory inspections in a key role for assigned programs, 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)
- Lead continuous improvement of the Clinical Quality Management System (CQMS), including creation and revision of SOPs and training programs for GCP compliance and excellence
- Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies related to GCPs
- Provide cross training development opportunities; mentor and coach junior QA team members
- Travel required
Pay
$192,700 – $226,700 a year
Employer providedThe pay range that the Company reasonably expects to pay for this headquarters-based position is $192,700 – $226,700; 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% below the US median for Clinical Quality & Safety roles at this level.
This roleEmployer provided
Director roles in California5 roles publishing pay
Director roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $192,700 | — | $226,700 |
| California (middle half) | $227,500 | $241,000 | $244,500 |
| All US (middle half) | $205,500 | $228,000 | $253,500 |
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 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance17
- Collaboration and leadership11
- Documentation and SOPs6
- Investigations and CAPA4
- Quality systems and risk4
- Regulatory submissions2
- Lab testing and methods1
- Data and digital systems1
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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Associate Director, Clinical Quality Assurance at Corcept Therapeutics
Open until filled. $193K–$227K a year, employer provided.