New · posted Oct 15
Corcept Therapeutics · Pharmaceuticals
Manager, Quality Operations
- 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.
Corcept is seeking a Senior Manager/Associate Director, Quality Operations to provide strategic and operational Quality leadership across commercial and clinical pharmaceutical manufacturing, testing, validation, disposition, and supply activities. This individual will serve as a senior Quality representative for CMC programs and external manufacturing and testing partners, helping ensure product quality, regulatory compliance, patient safety, and timely execution of Quality Operations deliverables in accordance with global cGMP requirements.
This is a hybrid role that typically requires on-site presence three days per week.
What you need
Preferred Education and Experiencenice to have
- Bachelor’s or Master’s degree in science, engineering, pharmacy, or a related field; advanced degree preferred
- 6+ years of progressive Quality Assurance experience in the pharmaceutical, biotechnology, or other regulated life sciences industry
- Strong working knowledge of 21 CFR Parts 210/211, 21 CFR Part 11, EU GMP, ICH guidelines, and other applicable global regulations governing the development, manufacture, testing, release, distribution, and control of pharmaceutical products
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
- An understanding of pharmaceutical manufacturing, analytical testing, validation, quality systems, and global cGMP expectations for commercial and clinical products
- Demonstrated ability to apply sound quality judgment, assess compliance risk, and make recommendations that support regulatory compliance, patient safety, product quality, and business continuity
- Experience with batch record review, product disposition, deviation management, CAPA, change control, validation, supplier quality, and quality agreement oversight
- Proven ability to lead cross-functional teams, influence stakeholders, and manage complex quality issues with internal departments and external partners
- Experience leading or supporting regulatory inspections and internal or external audits, including inspection readiness, response preparation, and remediation activities
- Ability to author, review, approve, and improve SOPs, quality agreements, risk assessments, technical reports, and other controlled documentation
- Strong analytical, problem-solving, and communication skills, including the ability to present quality risks, metrics, and recommendations clearly to senior management
- Ability to manage multiple priorities independently in a fast-paced, matrixed environment while maintaining compliance, accountability, and attention to detail
- Experience developing, analyzing, and presenting Quality metrics and trend reports
- Proficiency with Microsoft Word, Excel, PowerPoint, Visio, Smartsheet, and electronic quality management systems
- Ability to travel up to 20%
What you'll do
- Serve as a Quality Operations lead for complex CMC, commercial, and clinical supply programs by providing strategic quality direction, risk-based decision-making, and timely issue escalation
- Provide quality oversight of contract manufacturing organizations, contract testing laboratories, suppliers, and other external partners to ensure compliance with approved procedures, regulatory expectations, and quality agreements
- Review and approve GMP documentation, including batch records, analytical data, investigations, deviations, CAPAs, change controls, validation documentation, and product disposition records
- Lead or oversee quality investigations related to manufacturing, testing, packaging, labeling, storage, distribution, and product release activities, ensuring timely root cause analysis and effective corrective and preventive actions
- Review and approve validation protocols and reports, including process validation, analytical method validation, cleaning validation, packaging validation, and shipping lane qualification, as applicable
- Lead or support audits of suppliers, CLOs, CMOs, and service providers, including audit planning, execution, reporting, response evaluation, and follow-up of corrective actions
- Develop, monitor, and communicate Quality metrics and trend reports to identify compliance risks, recurring issues, and opportunities for continuous improvement
- Partner cross-functionally with CMC, Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Commercial teams to support submissions, inspections, product launches, and lifecycle management activities
- Mentor and guide Quality Operations staff and cross-functional team members, as applicable, to strengthen technical capability, inspection readiness, and operational excellence
Pay
$160,600 – $189,000 a year
Employer providedThe pay range that the Company reasonably expects to pay for this headquarters-based position is $160,600 – $189,000; 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 14% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in California25 roles publishing pay
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $160,600 | — | $189,000 |
| California (middle half) | $156,000 | $165,500 | $181,000 |
| All US (middle half) | $126,000 | $153,000 | $167,500 |
This role: Corcept Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Corcept Therapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance12
- Collaboration and leadership10
- Quality systems and risk9
- Lab testing and methods8
- Documentation and SOPs7
- Validation and qualification5
- Investigations and CAPA3
- Regulatory submissions2
- Data and digital systems2
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.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
Company 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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Manager, Quality Operations at Corcept Therapeutics
Open until filled. $161K–$189K a year, employer provided.