Manager, Clinical Quality Auditing
Manager, Clinical Quality Auditing
The Manager, Clinical Quality Auditing is an important liaison with Clinical Operations and Clinical Pharmacology teams to understand clinical development programs. Specifically, the Clinical Quality Audit Manager applies working knowledge and expertise in pharmaceutical research and quality assurance to provide consultation to clinical development teams and performs independent quality audits of clinical investigator sites and internal processes and systems. In addition, this role is important in ensuring effective corrective and preventive actions are in place to ensure continuing quality of clinical development programs. Where background and experience permit, this role also liaises with the Pharmacovigilance organization to understand audit needs and contribute to audit planning and conduct.
- Partner with Clinical Operations and Clinical Pharmacology to understand development programs and related risk factors to drive audit planning & scheduling. Attend project-team meetings and provide quality input as needed.
- Plan and conduct internal, external, routine and for-cause GCP and GVP audits worldwide, including audits in preparation for regulatory inspections.
- Guide functional teams through the deviation/CAPA process to ensure robust investigation, timely action and meaningful improvements to process.
- Using quality management system tools, analyze audit findings and deviation trends to drive continuous improvement.
- Provide guidance to employees, external contractors, clinical investigators, and development partners on topics related to clinical trial conduct, to facilitate identification and resolution of GCP-related issues and concerns.
- Support external contractors providing audit support, this may include providing information about company processes or guidance on use of the audit system.
- Develop and/or review Quality Management System documents.
- Train staff on regulatory requirements, quality management processes and procedures, and inspection readiness.
- Develop and deliver GCP training, or coordinate training via third party to clinical trial sites and investigators.
- Play a key role in the coordination of GCP and GPV regulatory inspections and train staff on the conduct of such inspections.
- Conduct or participate in Mock Regulatory Inspection activities and/or provide guidance to clinical development teams to facilitate inspection readiness.
- Perform Quality Control of documents and data as requested by project teams.
- Delegate/deputy for the Director, Clinical Quality Management
- 1 year of direct clinical quality auditing experience as Lead Auditor for all Clinical audit types
- Minimum of 5 years in a clinical setting.
- Ability to travel 35 – 50% of the time (domestic and internationally).
- Thorough knowledge of GCP regulations and the drug development process (inclusive of CSV).
- Experience with the principals of risk analysis and issue management (corrective and preventive action processes). Ability to perform risk assessments and successfully implement quality plans.
- Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, vendors contracted by Cerevel and/or clinical investigators.
- Excellent organization, problem solving and time management skills.
- Ability to work independently toward effective solutions.
- Skilled user of Microsoft Office applications such as Word, Excel, PowerPoint and MS Teams.
- Experience with Pharmacovigilance (GVP) auditing is preferred.
- Experience with the principals of risk analysis and issue management (corrective and preventive action processes).
- Ability to perform risk assessments and successfully implement quality plans.
- Experience developing and presenting training.
B.S. Degree in Science, Nursing or related field.
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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