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Corcept Therapeutics
Menlo Park, CA | Full Time
$149k-175k (estimate)
1 Month Ago
Manager, Computer Systems Validation (CSV)
Corcept Therapeutics Menlo Park, CA
$149k-175k (estimate)
Full Time | Pharmaceutical 1 Month Ago
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Corcept Therapeutics is Hiring a Manager, Computer Systems Validation (CSV) Near Menlo Park, CA

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.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$149k-175k (estimate)

POST DATE

02/18/2023

EXPIRATION DATE

08/24/2023

WEBSITE

corcept.com

HEADQUARTERS

MENLO PARK, CA

SIZE

200 - 500

FOUNDED

1998

CEO

JOSEPH K BELANOFF

REVENUE

$200M - $500M

INDUSTRY

Pharmaceutical

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