Sr Manager, Quality Systems Training & Document Control

The Quality Systems Manager will play a significant role in maintaining Corcept’s Quality Management Systems. Reporting to the Director, the Quality Systems Manager will assume management and operational ownership of GxP Training and Document Control programs which include breadth of developing and implementing program strategy, planning, and organizing projects, and performing tactical hands-on work.

Responsibilities

• Lead key strategic program to launch the Document Control program including defining business processes with stakeholders and partnering with team to support software configuration needs.
• Lead enhancements to the system to improve efficiency and reduce manual processes.
• Work with cross functional groups to evaluate training assignments, develop and maintain training matrices, and drive training completion timeliness.
• Play active role in end user education and effective training on document change controls (DCCs), use of template, Veeva workflow including reviews and approvals.
• Archive and maintain legacy controlled documents.
• Manage and lead legacy document migrations into electronic document management system.
• Effectively manage periodic reviews of SOPs and Quality Agreements in addition to supporting the revision of existing Quality Agreements
• Support enhancement and administrative updates to the electronic quality management systems
• Develop effective and engaging training materials using Articulate.
• Manage and lead risk assessments for respective electronic systems.
• Effectively manage vendor relationships and deliverable expectations.
• Author and own quality events related to Quality Systems that include deviations, CAPAs, investigations, and change controls.
• Create periodic reports for training and document control to track and trend and follow up with personnel as needed.

Preferred Education and Experience

• Bachelor’s degree
• 5+ years of relevant work experience in the biotechnology or pharmaceutical industries or relevant comparable background
• Advanced proficiency and hands-on experience with Electronic Document Management and Learning Management Systems and others (preferably, Veeva Vault, and ComplianceWire, Articulate, DocuSign)
• Knowledge of quality systems, 21 CFR 11, 210 and 211, GAMP-5, ICH-Q10, data integrity
• Familiarity with electronic system implementation, software development lifecycle (SDLC) and system maintenance
• Exercise judgment within well-defined and established processes and practices to determine appropriate action.
• Detail-oriented with good project management and organization skills
• Able to work independently and collaboratively to achieve common goals.
• Clear and concise communication (written and verbal)
• Proficiency with Microsoft Office tools (Excel, Word, Visio, Project, and PowerPoint)

The pay range that the Company reasonably expects to pay for this position is $176,500 - $208,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered. 

Applicants must be currently authorized to work in the United States on a full-time basis.

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