An international biologics company that works to develop and manufacture Biosimilars is looking for a Clinical Quality Manager to work on a remote basis to support the Quality team with their Clinical Activities. The team is looking for a person that has a fundamental understanding of Quality from a GCP perspective, experience of auditing is an added bonus.

Your tasks:
* Risk based audit planning for vendors and clinical sites
* Contributing to clinical program design and execution according to internal SOPs and international standards and providing appropriate Quality input and guidance
* Performing Quality reviews of TMFs and other essential clinical documents
* Reviewing and approval of clinical SOPs to ensure compliance with international standards
* Supporting and contributing to major Health Authority inspections, in close alignment with the Compliance & Inspection Readiness team
* Assisting in preparation, reviewing and approval of regulatory filings (such as: INDs, BLAs, Annual Reports)
* Supporting and contributing to major Health Authority inspections, in close alignment with the
Compliance & Inspection Readiness team
* Defining Quality related training needs for the clinical development area, supporting and
reviewing training plans and monitoring the timely execution, organising and conducting GCP
related training modules

Your qualification:
* Master's or PhD degree in a relevant field (medicines, pharmacy, biotechnology, biochemistry, chemistry)
* Over 5 years of experience in clinical R&D (Clinical Operations and/or Clinical Quality Assurance), including vendor management
* Proven experience in risk based approaches
* Experience with GCP inspections
* Excellent knowledge of ICH GCP guidelines, EMA, FDA and other relevant regulations
* Excellent computer skills and understanding of IT landscapes used in clinical studies
* Strong skills and willingness to work and communicate cross-functionally
* Ability to work adapt to the company and local culture
* Very good command of English language, knowledge of or willingness to learn Polish would be
* an advantage

If interested please apply directly