Description
The Clinical QA Manager/Sr. Manger is responsible for representing quality in clinical project team meetings ensuring studies are performed in compliance with company procedures and all applicable GCP regulatory requirements.Duties and Responsibilities:
- Represent QA in clinical sub-team meetings.
- Identify, revise or assist with the development of quality systems for Clinical QA and Clinical Operations to enhance execution, compliance and quality of studies.
- Partner with Clinical Operations to identify process improvements (best practices) and new technologies for building proactive quality into the scientific and operational design and conduct of clinical trials.
- Develop and implement written quality management plans to support all Clinical development activities for corporate projects.
- Review scientific protocols, technical reports and other documentation in support of drug development and regulatory submissions.
- Work with Regulatory Compliance to ensure audits of CRO's, specialty service providers (i.e., EDC, e-diaries, IVRS, etc.), data base audits, clinical sites and regulatory documents are performed in accordance to project team timelines. Support Regulatory Compliance as needed and assist with regulatory inspection readiness activities as required.
- Maintain current knowledge of regulatory requirements and thorough understanding of inspection trends, designs programs that advance proactive quality management systems designed to meet requirements in a cost effective manner.
- Develop quality indicators, metrics and trending tools to provide a process for monitoring effectiveness of quality systems and continual improvement opportunities.
- Provide GCP training sessions for internal and contract personnel in support of clinical development objectives.
Job Requirements:
- B.S. or advanced degree in science, nursing or related health sciences discipline with a minimum 8 to 10 years experience in the pharmaceutical / biopharmaceutical Quality with a minimum of 5 years direct experience managing Clinical Quality Assurance.
- Strong working knowledge and interpretation/implementation of FDA regulations, ICH -GCPs, familiarity with worldwide regulatory guidelines, and experience dealing with regulatory authority inspections is a plus.
- Ability to deal with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple.
- Experience with developing effective quality systems, writing SOP, process flow diagrams; working knowledge of software applications used in clinical development and familiarity 21CFR Part 11 requirements.
- Some travel may be required (avg. 25% or less)
To find out more about Real please visit www.realstaffing.com