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…
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Skills: MES, POMs, Recipe authoring, Computer systems validation, Project management
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Senior$650K raised
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Cranial Technologies is the only company in the world completely dedicated to researching and treating plagiocephaly (commonly called flat head syndrome). With over 500,000 babies successfully treated, we are the plagioc…
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Cranial Technologies is the only company in the world completely dedicated to researching and treating plagiocephaly (commonly called flat head syndrome). With over 500,000 babies successfully treated, we are the plagioc…
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$161k–$189k/yr
Full-time
Posted 6d ago
~40 hrs/week
Responsibilities
The Manager of Computer Systems Validation is responsible for the implementation, management, and ongoing support of internal GXP validated systems. This role ensures IT quality and risk management standards are met while guiding business teams through validation principles throughout the system lifecycle.
Requirements
Candidates must have 8+ years of experience in QA or validation within a pharmaceutical or biotech environment. Proficiency in industry standards such as 21 CFR Part 11, GAMP5, and ICH Q9 is required.
Full job description
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.
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.
Pioneering the discovery and development of cortisol modulators.
Industry
Biotechnology Research
Company size
501-1,000 employees
Founded
1998
Headquarters
Redwood City, California
LinkedIn followers
73,683
Total funding
$119M
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.
Offices: 101 Redwood Shores Pkwy, Redwood City, California 94065, US
Based on 11928 listings with disclosed salaries, most healthcare jobs in California pay between $84k–$230k per year. Individual offers vary with seniority, company size, and specialization.
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