Are you looking for a job with influence, exciting scientific challenges, and an opportunity to use and develop your leadership skills? Then this may just be the job for you.
The client is a clinical- stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases,
They are investing heavily in their team to make sure they have the right people to drive them forward to their next step. They are looking to change the landscape of autoimmune diseases, could you be the one to help them?
Apply Now!
Key requirement:
- A minimum of Bachelor's degree in STEM (Science, Technology, Engineering, and Math
- At least seven 7 years of pharmaceutical/biotech/medical device GCP Quality Assurance
- Quality Management or Clinical Compliance experience in Phase 1 - 4 clinical trials including non-interventional studies
- Strong working knowledge and interpretation of global GxP regulations in drug development from pre-clinical to post-marketing safety, particularly U.S. FDA/EU and ICH regulations and guidelines
- Broad and direct experience with competent authority inspections such as US FDA GCP BIMO Inspections (Sponsors, CROs, and/or Clinical Investigators), Pre-Approval Inspections (PAIs), etc.
Key responsibilities:
- Author, maintain and implement study-specific Clinical Trial Quality Management Plan(s) for assigned clinical program(s) and trial(s) to ensure the execution of a phaseappropriate, fit-for-purpose Audit Program
- Represent Quality at cross-functional clinical program meetings and Clinical Study Team meetings and operational activities to provide appropriate Quality guidance on GCP compliance matters to internal departments.
- Identify, mitigate, or escalate clinical quality risks by leveraging GCP knowledge and best practices across all phases of clinical development.
- Maintain program oversight and influence proactive quality management through quality related activities with regard to vendor management, study conduct, and study records
- Author and/or review QMS controlled documents which may include standard operating procedures (SOPs) in accordance with applicable regulatory requirements (e.g., ICH E6, FDA, EMA, MHRA, local regulations)
- Oversee the implementation of appropriate and timely CAPAs.
- Participate in risk review meetings and review study Risk Management Plans.
- Conduct QA reviews of essential documents including as applicable Clinical Protocols, Study Plans/Manuals, Investigator Brochures, Investigator's Brochure, for ensuring quality, accuracy, and completeness
- Collaborate with internal and/or external stakeholders to ensure management of GCP quality issues, CAPAs, and change controls
- Identify process improvements to build compliance into the design and conduct of clinical activities
