Clinical QA Manager
Warszawa
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your role:
If you are a Clinical Quality professional who enjoys working in dynamic environment and you are looking for a meaningful career opportunity where you would be responsible for managing all aspects of Clinical Quality Assurance in a fast growing biotech company, this role might be the right opportunity for you.
In this role you will closely interact with the clinical team, provide risk based advice on GCP and related topics. Further you will contribute to build a state of the art Clinical Quality Assurance Function, oversee QMS-related activities and perform audit planning and ensure CAPAs are implemented.
Your responsibilities:
- Risk based audit planning for vendors and clinical sites
- Essential, pro-active contribution to development, continuous improvement and maintenance of the Clinical Quality Management System
- Reviewing and approval of clinical SOPs to ensure compliance with international standards
- Contributing to clinical program design and execution according to internal SOPs and international standards and providing appropriate Quality input and guidance
- Defining and supporting implementation of documentation standards for record-keeping and archiving for clinical documentation (both paper and electronic)
- Implementing measures for oversight and monitoring of clinical vendors according GCP requirements, including CROs and bioanalytical laboratories
- Performing Quality reviews of TMFs and other essential clinical documents
- Managing clinical non-compliances and acting as a contact person for Quality issues in clinical development
- Support the Compliance & Inspection Readiness team to establish and prioritize audit programs for clinical studies
- Support the clinical team to identify root-causes and ensure the implementation of CAPAs
- 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, organizing and conducting GCP related training modules
If you have:
- 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 willingness to learn Polish would be an advantage