New · posted Oct 15
Corcept Therapeutics · Pharmaceuticals
Manager, Computer Systems Validation (CSV)
- Redwood City, CA
- On-site
- 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 Manager, Computer Systems Validation (CSV) will be a core member of the Quality Systems Technology team and responsible for the implementation, management, ongoing support and review of Corcept’s internal GXP validated systems. This individual will ensure IT Quality and Risk Management standards are defined, understood, designed into work activity, and achieved. This position will manage day-to-day operations for IT Compliance and Risk Management, working closely with key stakeholders from business teams, particularly QA, heavily guiding business teams on validation principles and requirements throughout the system lifecycle. This role will ensure compliance risks are identified, mitigated, and managed appropriately.
What you need
Preferred Education and Experiencenice to have
- 8+ years’ experience in QA or Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharma/biotech environment
- Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 210, 211& 11, Annex 11, GAMP5, ICH Q9, Data Integrity, CSA
Skills, Qualifications, or Technical Proficiencies
- Thorough understanding of validation/qualification and concepts as it applies to pharmaceutical quality systems
- Excellent communication skills with the ability to effectively communicate across organizational levels and functions
- Proficiency with Veeva QualityDocs / QMS and ComplianceWire
- Experience with CTMS and Regulatory systems
- Ability to manage external software and consultant vendors
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.
What you'll do
- Provide assessment/review/oversight for Enterprise / GXP computer systems validation (focus on Pharmaceutical Systems)
- Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies
- Ensure compliance and the validated state of all GXP systems
- Provide validation guidance on data migration activities as needed
- Provide IT assessment and approval for GXP computer system changes
- Develop and support testing of proposed changes in system development environments
- Experience in authoring and managing documents such as change control, Risk Assessments, Validation Plans, User Requirements Specifications, Functional Specifications, qualification protocols (IQ/OQ/PQ), Traceability Matrix, system procedures, deviations and CAPAs
- Coordinate and support vendor support release activities
- Support and provide guidance to cross-functional groups with GXP system implementation projects and ongoing validation needs including system enhancements, releases and revalidation
- Responsible to manage external CSV consultants in CSV projects
- Responsible as interface between IT and QA
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, CAOn-siteOpen 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 24% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Manager roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $160,600 | — | $189,000 |
| All US (middle half) | $135,500 | $141,000 | $164,000 |
This role: Corcept Therapeutics's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 111 open Validation & CQV 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 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification9
- GMP and compliance7
- Data and digital systems7
- Quality systems and risk4
- Collaboration and leadership4
- Documentation and SOPs3
- Lab testing and methods1
- Investigations and CAPA1
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 data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- 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, Computer Systems Validation (CSV) at Corcept Therapeutics
Open until filled. $161K–$189K a year, employer provided.