Manager, Computer Systems Validation (CSV)
About this 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.
Responsibilities:
- 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
Preferred Education and Experience:
- 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
The 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.
Applicants must be currently authorized to work in the United States on a full-time basis.
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.
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
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.
Company at a glance
We’ve been unlocking the potential of cortisol modulation for more than 25 years.
We’re leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.
In 2012, we received FDA approval of a groundbreaking cortisol receptor blocker and the first approved treatment for hypercortisolism (Cushing’s syndrome).
Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
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