The Associate Director of Process Development and Documentation in Clinical Quality Assurance (CQA) is a key member of the CQA team and will lead and perform day-to-day clinical quality operations and compliance activities related to developing and documenting processes to support the success of the clinical studies sponsored or supported by Corcept.
Responsibilities: Lead process development and documentation activities working with Clinical Development functional teams to support success of the clinical studies sponsored or supported by Corcept Lead and/or manage cross-functional teams for the development of GCP, GVP and GLP SOPs. Working with functional areas to support their process development and writing of SOPs and to ensure that SOP reviews and updates are happening within expected timelines Serve as a Clinical Quality Assurance SOP representative and support clinical study teams to provide process compliance advice during team meetings or other methods of communications Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents as required Manage SOP development timelines and plans to ensure compliance with SOP review requirements and regulatory driven updates using risk-based approach Lead continuous improvement of the Quality Management System (CQMS), including creation and revision of SOPs and training programs for GCP, GLP and GVP compliance and excellence Lead and/or manage and support inspection readiness and preparation activities for development organization Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigator site inspections, and contract research organization (CRO) inspections. Support GMP, GLP, and PV inspections as needed Support qualification audits of GCP, GLP and GVP service providers, clinical investigator sites, clinical department internal audits, and applicable study document audits, including review of TMFs and CSRs and with specific focus on required and expected SOPs Lead and/or support clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checks Support the management and growth of the Clinical Quality Assurance team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team's capabilities meet Corcept's future needs Perform quality metric analysis for CQA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies related to process best practice and SOPs within the pharmaceutical development space. Identify relevant developments, understand impact and develop plans for compliance Provide cross training development opportunities Mentor and coach junior QA team members Minimal travel required Preferred Skills, Qualifications and Technical Proficiencies: Demonstrated technical writing skills are required Experience in process development, mapping and documentation Experience in developing GCP, GLP and GVP processes for the best industry practices and training personnel regarding SOPs and the regulations to which they apply Ability to prepare for and support regulatory agency inspections Thorough understanding of the quality systems that support internal GCP, GLP and GVP activities for clinical documentation and commercial products Excellent in basic Microsoft Office applications (Word, Excel, PowerPoint) is required Preferred Education and Experience: BA/BS degree in biological sciences, pharmacy, related field or equivalent experience is required 10+ years' experience in process development and specifically developing and maintaining clinical research SOPs for clinical stage pharmaceutical companies The pay range that the Company reasonably expects to pay for this headquarters-based position is $183,300 - $215,600; 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.
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