CSV Manager, Quality Systems Technology (QST)

The primary responsibilities of a CSV Manager at Corcept include driving continuous improvement initiatives for our Quality Management System (QMS), collaborating with IT and QA teams to ensure compliance of validated systems, and monitoring periodic system reviews to identify compliance gaps. The CSV Manager supports regulatory inspections, assists in developing GxP SOPs, and plays a crucial role in inspection remediation and CAPA closure, all while ensuring compliance with GxP regulations.

To qualify for the CSV Manager position at Corcept, candidates should ideally have over 8 years of experience in the development and maintenance of quality systems in pharmaceutical companies. A thorough understanding of ICH Q10, GAMP 5, and regulations like 21 CFR Part 11 is essential. Proficiency in GxP-validated systems such as Veeva and experience in developing GxP SOPs and conducting training will also enhance a candidate's application.

Corcept values the commitment and hard work of its team members and actively promotes professional growth. As a CSV Manager, you will have the opportunity to collaborate with various departments, gain exposure to regulatory compliance processes, and further your knowledge in GxP standards and quality systems. The company also encourages continuous learning through training programs and development initiatives.

As a CSV Manager at Corcept, you will work with several GxP-validated systems including Veeva for electronic trial master files, SAS for data analysis, and ComplianceWire for training management. Familiarity with these tools will help you monitor compliance, enhance system usability, and manage documentations related to regulatory standards effectively.

Corcept's company culture is centered around collaboration, innovation, and dedication to improving patient outcomes. In the role of CSV Manager, you will work closely within cross-functional teams, fostering relationships that empower continuous improvement and compliance. The company promotes transparency and support, ensuring all team members contribute to advances in healthcare together.

When answering this question, provide specific examples of GxP-validated systems you've worked with, such as Veeva or ComplianceWire. Discuss your role in ensuring compliance, any challenges faced, and how you overcame them. Highlight your understanding of regulatory requirements and your proactive approach to managing system validations.

Focus on outlining your approach to assessing compliance risks associated with system updates. Describe your method for collaborating with cross-functional teams, performing impact assessments, and implementing validation protocols to maintain GxP compliance. Highlight any relevant experience that demonstrates your attention to detail and commitment to integrity.

Talk about specific strategies you’ve implemented, such as establishing metrics for performance evaluation, conducting regular audits, and gathering feedback from users. Emphasize your ability to analyze data trends and lead initiatives that enhance efficiency and compliance within the Quality Management System.

Provide a detailed response by recounting your involvement in preparations or your role during the inspection. Discuss how you ensured documentation accuracy, facilitated communication with auditors, and addressed any non-compliance issues that arose. This demonstrates your experience and capacity to handle high-pressure situations.

Share your methods for staying informed, such as attending industry conferences, subscribing to relevant journals, or participating in professional networks. Illustrate your commitment to continuous education and how you apply new knowledge to your work, which is crucial for a CSV Manager role at Corcept.

Explain your understanding of SOP development processes, including the importance of regulatory requirements and practical applicability. Discuss how you collaborate with relevant stakeholders, ensure clarity in instructions, and implement an effective training strategy to facilitate understanding and compliance among personnel.

Detail your methods for prioritization, including assessing urgency, identifying dependencies, and effectively communicating with team members about timelines or changes. Demonstrating flexibility and the ability to adapt to changing priorities is vital for success in a fast-paced organization like Corcept.

Identify common challenges such as evolving regulations, maintaining data integrity, and ensuring cross-team collaboration. Discuss how awareness of these challenges can inform proactive strategies and your readiness to tackle them to ensure compliance and advancement in quality management.

Describe your structured approach to training, which might include creating easy-to-understand training materials, conducting hands-on workshops, and measuring training effectiveness through assessments. Highlight your ability to engage trainees and build a culture of compliance within the organization.

Share your knowledge and experience with risk assessment techniques you have utilized during system validation. Highlight how you can prioritize validation activities based on risk and impact, ensuring that critical system features are addressed to meet GxP standards.