Compliance QA/RA Expert
Walloon Brabant – contracting
What are your responsibilities?
- QA oversight for regulatory compliance change controls
- QA oversight for compliance risk assessment reports.
- The completion of regulatory advice 1 assessments for multi-sites change controls.
- The timely delivery of the global documentation (e.g. SOPs) updates linked to the site conformance and regulatory compliance processes in compliance with internal requirements.
- Participate as global site conformance partner for Global Supply Chain change control boards.
- Act as global site conformance role to deliver and implement initiatives and improvement programs management
- Ensure the continued compliance of the company products versus registered details in collaboration with local Site Conformance network and technical regulatory department across the whole organization
- Ensure close collaboration with global and regional regulatory affairs teams by provide quality oversight to the CMC regulatory processes such as building of regulatory dossiers and management of regulatory approval conditions
- Ensure quality culture and mindset, through participation as QA partner to RA initiatives aimed at improving the end-to-end CMC process (e.g. the Regulatory Submission Building Process task force, etc).
- Driving alignment across site conformance network through site conformance network meetings and workshops.
- Lead project-related discussions and provides in-depth strategic, scientific and RA input for technical/CMC and procedural aspects.
Who are you?
- Preferably PharmD with master degree in regulatory affairs or quality
- At least 6 years of experience in Quality & Regulatory domains (pharma/vaccines industry)
- Knowledge of Vaccine regulatory, quality, testing and/or manufacturing environment, preferably
- Strong knowledge of regulations, guidance's and industry standards related to CMC processes
- Quality mindset with good knowledge of pharmaceutical operations (including manufacturing and testing of vaccines) and Quality Systems, Good Manufacturing Practices (GMP) as well as Regulatory matters
- Demonstrated expertise and knowledge of regulated environment (CMC or GMP) in vaccines industry
- Excellent project management expertise, with level of accountability, and drive for success.
- Excellent written and spoken English is a must, French is an advantage
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We invite you to apply !
Do you have any questions? You can contact Anaïs Malikian, [email protected]