Quality Systems GxP Training Specialist II

Corcept Therapeutics Incorporated; Redwood City (CA); Hybrid; USD 106,000 - 125,000; Full time

Job summary

Corcept Therapeutics Incorporated is seeking a GxP Training/ LMS specialist to support the training program across GxP departments. You will manage training items, curricula, and reporting, collaborating with HR, IT, and department leads to ensure compliance and effective onboarding.

Ideal candidates have a BA/BS in a science-related field and 5+ years in pharma or life sciences, with hands-on experience in ComplianceWire or Veeva Training. This hybrid, headquarters-based role reports to the Sr.

Qualifications

• BA/BS degree in a scientific/technical/engineering field.
• 5+ years in pharmaceutical or life sciences environments.
• Experience with GxP training programs and LMS platforms.

Responsibilities

• Assist in LMS administration: create training items, curricula, reports, and user support.
• Support GxP Training Leads to strengthen training compliance using reports and metrics.
• Review training materials (SOPs, work instructions) and add them to curricula.
• Coordinate onboarding activities with HR/IT and managers for LMS assignments.
• Prepare and share training attendance records and training status reports.

Skills

Organizational skills

Communication

Multitasking

Education

BA/BS in science/engineering

Tools

ComplianceWire LMS

Veeva Training

MS Office

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.

This role is a core member of the Quality Systems team and works on activities and tasks that support the GxP training program. This role requires an adaptable, self-starter that can independently assess issues and propose solutions for systems like ComplianceWire used to manage training compliance. This position reports to the Sr. Manager of Document Control and GxP Training.

This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities:

• Perform administrative tasks in the LMS including creation of training items or curricula, support for system enhancements, troubleshooting issues with user accounts or training access, and monitoring and sharing reports to drive training compliance
• Support cross-functional GxP Training Leads in strengthening training compliance using instructor led training, reports and metrics, and education on GxP training matrix
• Assess training qualification materials, including but not limited to SOPs and work instructions, ensuring they are appropriately added into training curricula across various GxP departments
• Assess existing curricula to determine if additional training items, like work instructions, should be added to support learning
• Support onboarding activities by working with HR, IT, and managers to identify training roles and requirements prior to making assignments in the LMS
• Support hiring managers in their understanding of the GxP training matrix and work with GxP Training Leads to determine if revisions are required
• Support supplemental training activities including on-the-job training and instructor-led training
• Collect and report training metrics using reporting functionality in the LMS
• Design dashboards to expand visibility on training compliance at the department level
• Identify and elevate gaps and discrepancies in the GxP training program and propose solutions for remediation
• Assist with training attendance records and cataloging and filing activities, as well as uploading completed forms into the Learning Management System (LMS)
• Assist in the implementation of new LMS enhancements or systems
• Capture detailed meeting minutes, action items, and key decisions
• Assist in drafting internal communications for events and training status reports
• Coordinate and schedule lunch and learn training sessions, office hours, and other supplemental training events
• Promptly respond to email inquiries and user support questions using ticketing systems like Zendesk

Preferred Skills, Qualifications and Technical Proficiencies:

• Experience with electronic Learning Management Systems (ComplianceWire LMS and Veeva Training preferred)
• Experience supporting GxP training programs for life sciences
• Proficient in the use of MS Office applications (Excel, Word, Visio, Teams)
• Excellent organizational skills and the ability to manage multiple competing tasks
• Excellent communication skills with the ability to collaborate with a wide range of stakeholders in various departments

Preferred Education and Experience:

• BA/BS degree in a scientific/technical/engineering field
• 5+ years of experience in pharmaceutical or life sciences organizations

The pay range that the Company reasonably expects to pay for this headquarters-based position is $106,200-$124,900; 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.

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.

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