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Manager, Computer Systems Validation (CSV)

Employer
Corcept Therapeutics
Location
Menlo Park, CA
Start date
Mar 19, 2023

View more

Discipline
Information Technology, System Administration, General
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym® for the treatment of patients suffering from Cushing’s syndrome, a life-threatening orphan disorder caused by excess cortisol activity. In 2022, we generated revenue of $402 million and net income of $101 million.

We have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.  Our lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer and amyotrophic lateral sclerosis (“ALS”).  We plan to initiate a Phase 2b trial in patients with non-alcoholic steatohepatitis (“NASH”) by the end of this year.  Every year, we advance new molecules to the clinic.

Over the next few years, we expect to submit several new drug applications.

Reporting to the Director, Information Technology the Manager, Computer Systems Validation (CSV) will be a core member of the Information 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 individual 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 principals and requirements throughout the system lifecycle.  This role will ensure compliance risks are identified, mitigated and managed appropriately  

Responsibilities

  • Provide IT 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
  • Experience in writing and managing documents such as change control, developed/executed Validation Plans, User Requirements Specifications, Functional Specifications, Traceability Matrix, Risk Assessments, system procedures, equipment/instrument qualifications (IQ/OQ/PQ), computer validation (CSV) and process validations (PV)
  • 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 revalidation, periodic review of system controls, security, and segregation of duties.
  • Responsible to manage external CSV consultants in CSV projects
  • Responsible as interface between IT and QA

Preferred Education and Experience

  • 8+ years of work 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 11, Annex 11, GAMP5, ICH 10

Skills, Qualifications, or Technical Proficiencies

  • Thorough understanding of validation/qualification and concepts as it applies to pharmaceuticals quality systems
  • Must have excellent communication skills (both oral and written including the ability to effectively communicate across organizational levels and functions
  • Proficiency in the use of Veeva QualityDocs / QMS and ComplianceWire
  • Experience with CTMS and Regulatory systems
  • Ability to manage external software and consultant vendors

The pay range that the Company reasonably expects to pay for this position is $136,000 - $195,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered. 

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.

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.

 Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer

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