Sr. Specialist, Quality Systems Technology (QST)

As a Sr. Specialist, Quality Systems Technology (QST) at Corcept, your primary responsibilities will include managing Veeva Quality (QMS and QualityDocs) and ComplianceWire systems. You'll be tasked with overseeing user access management, ensuring compliance with regulatory standards, and optimizing workflows for quality processes like deviations and change control. Your role will also involve monitoring system performance and collaborating with different teams to enhance system efficiency.

To excel as a Sr. Specialist, Quality Systems Technology (QST) at Corcept, candidates should hold a BA/BS degree in a scientific or engineering field and have a minimum of 6 years of experience in Pharmaceutical Quality Systems. Advanced proficiency in Electronic Document Management and Learning Management Systems, particularly Veeva and ComplianceWire, is essential. Strong communication and interpersonal skills are also needed to work effectively with both technical and non-technical stakeholders.

For the Sr. Specialist, Quality Systems Technology (QST) role at Corcept, preferred skills include hands-on experience with Veeva Vault applications, specifically regarding the configuration of workflows and security settings. Moreover, familiarity with the principles of validation as applied to computerized systems is beneficial. Candidates should also demonstrate effective prioritization skills and a customer-centric approach to problem-solving.

The work environment for the Sr. Specialist, Quality Systems Technology (QST) position at Corcept is hybrid. This means candidates can expect a blend of working from home and at the Redwood City office, requiring on-site presence three days a week. This setup allows for collaboration with the team while also providing flexibility in remote work.

Corcept is dedicated to the professional development of its employees, including those in the Sr. Specialist, Quality Systems Technology (QST) role. The company encourages continuous learning and might provide access to training programs, workshops, and conferences related to quality systems and compliance, which can help enhance your expertise and career growth within the organization.

When answering this question, focus on your hands-on experience with Veeva Quality and ComplianceWire, highlighting specific projects where you utilized these systems. Discuss the workflows you managed, any improvements you implemented, and how you ensured compliance with regulatory standards.

In your response, elaborate on your methods for user access management, including how you maintain security and control of user permissions. Describe any frameworks or best practices you follow to ensure that the right users have appropriate access levels while maintaining compliance with regulations.

Share your approach to identifying inefficiencies, such as conducting audits, engaging team feedback, and analyzing process data. Offer examples of previous instances where you've identified inefficiencies and the corrective measures you implemented to enhance operations.

Provide a detailed account of a project where you successfully optimized a quality system. Explain your objective, the steps you took, the challenges you faced, and the positive outcomes achieved. Highlight any metrics or improvements that showcase your impact.

Discuss your systematic approach to ensuring compliance, such as staying updated with regulatory changes, performing regular system reviews, and educating team members about compliance requirements. Mention any relevant standards or guidelines that you rigorously follow in your operations.

In your response, emphasize the importance of clear, concise communication and building rapport with cross-functional teams. Discuss various strategies you've adopted, such as regular meetings, collaborative tools, and feedback loops to ensure everyone is aligned and engaged.

Address your time management strategies, such as creating a clear prioritization matrix, leveraging tools for task organization, and setting realistic deadlines. Share an example of when you successfully multitasked under pressure without compromising quality.

Discuss the transformative impact that technology has on quality systems management. Highlight how automation, real-time data analysis, and advanced software applications like Veeva can streamline processes, increase efficiency, and enhance compliance.

Outline your preparation process for inspections, such as maintaining meticulous documentation, conducting internal audits, and organizing mock inspections. Highlight the importance of fostering a culture of readiness and compliance among team members.

In your answer, connect your passion for pharmaceutical quality systems with Corcept's mission in advancing cortisol modulation treatments. Express your enthusiasm for contributing to innovative projects and the positive impact on patient care and drug development.