Quality Systems GxP Training Specialist II

Regulatory Toolkit; Redwood City (CA); Hybrid; USD 106,000 - 125,000; Full time

Job summary

Corcept Therapeutics is seeking a Quality Systems professional to support the GxP training program. Hybrid role requiring on-site presence three days per week, reporting to the Sr. Manager of Document Control and GxP Training.

You will manage LMS tasks (ComplianceWire, Veeva Training), create curricula, monitor compliance, generate reports, and collaborate with HR, IT, and department leads to improve training effectiveness and documentation.

Qualifications

• Experience with electronic Learning Management Systems (ComplianceWire LMS and Veeva Training preferred).
• Experience supporting GxP training programs in life sciences/pharma.
• Proficient in MS Office applications (Excel, Word, Visio, Teams).
• Excellent organizational skills and ability to manage multiple tasks.
• Excellent communication with diverse stakeholders.

Responsibilities

• Perform LMS administrative tasks: create training items/curricula, support system enhancements, troubleshoot access, share reports to drive compliance.
• Support GxP Training Leads in strengthening training compliance with instructor-led training and metrics.
• Assess training materials (SOPs/work instructions) for inclusion in curricula across GxP departments.
• Evaluate curricula to determine need for additional training items.
• Assist HR/IT to identify training roles and LMS assignments.
• Help hiring managers understand the GxP training matrix and revisions.
• Support supplemental training (on-the-job, instructor-led).
• Collect and report LMS metrics and design dashboards for visibility.
• Identify gaps in GxP training and propose remediation solutions.
• Assist with attendance records, filing, and uploading forms into the LMS.
• Assist in implementing LMS enhancements or new systems.
• Capture meeting minutes and action items.

Skills

MS Office

Communication

Organization

Stakeholders

Education

BA/BS in science/engineering

Tools

ComplianceWire LMS

Veeva Training

Zendesk

MS Visio

Teams

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 questionsusing 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.