Senior Specialist, Quality Systems Technology (QST)

Redwood City, California, United States

Corcept is 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 Korlym® (mifepristone), 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.

Join our dynamic team as a Sr. Specialist, Quality Systems Technology (QST) to support and optimize Veeva Quality (QMS & QualityDocs) and ComplianceWire (LMS). In this role, you are responsible for executing technical tasks to support key quality processes. These include deviations, change control, CAPA, document management, and training. In addition, you are responsible for maintaining security settings, ensuring compliance and operational efficiency, and supporting validation activities.

You will also assist with system testing, configuration, and assessment, establish and deliver compliance reporting, and provide input on process operation and documentation.

This role requires cross-functional collaboration to ensure processes are completed timely and accurately, streamline operations, and support QST in maintaining regulatory compliance. Make an impact by providing seamless system operation in a fast-paced environment. This is a hybrid role that requires on-site presence at least 3 days per week.

Responsibilities:

  • Administer and execute technical processes in Veeva Quality (QMS and QualityDocs) ensuring accuracy of data, supporting user input, enacting minor configuration updates, and providing validation support
  • Provide support for the Learning Management System (ComplianceWire)
  • Support validation activities by running test scripts for Veeva Quality (QMS and QualityDocs) and ComplianceWire
  • Monitor system performance and address technical issues and user needs promptly to maintain system integrity and process efficiency
  • Identify process and system inefficiencies and recommend improvements
  • Provide basic guidance and support to Corcept personnel on system functionality, including training of new users
  • Contribute to inspection readiness efforts by supporting logistics, generating reports, and responding to requests

Required Skills and Qualifications:

  • Advanced proficiency with core quality processes in Veeva and ComplianceWire, including document control, CAPA, deviations, change control, and training
  • Experience writing and revising SOP, Work Instructions, and related documents
  • Demonstrated experience supporting validation of computerized systems and processes
  • Working knowledge of regulations within the pharmaceutical industry, particularly GMP, GCP, and 21 CFR Part 11/EU Annex 11
  • Effective communication and interpersonal skills; capable of training both technical and non-technical users in system functionality
  • Customer-focused and able to prioritize tasks when presented with competing priorities with internal stakeholders

Preferred Skills and Technical Proficiencies:

  • Experience as a system administrator of Veeva Vault, including configuring applications, workflows, lifecycles, and security settings. Veeva Vault System Administrator Certification is a plus
  • Proficient with core CSA principles
  • Experience developing training materials and establishing training programs for EDMS and/or EQMS
  • Working knowledge of ICH Q10

Preferred Education and Experience:

  • BA/BS degree in a scientific/technical/engineering field, or equivalent combination of education and experience
  • 5+ years experience in pharmaceutical quality systems or equivalent

The pay range that the Company reasonably expects to pay for this headquarters-based position is $127,400 - $149,900; 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.

 

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