Compliance Specialist ensuring clinical trials meet the highest quality standards at Johnson & Johnson. Collaborating with teams in Belgium and The Netherlands for regulatory compliance.
Responsibilities
Proactively monitor compliance risks and metrics and install timely mitigation actions
Contribute in implementing local quality plans
Perform on-site compliance monitoring visits, supervise progress and confirm efficiency of remediation plans and conduct QC checks on trials and processes
Support preparation and oversight of inspections and audits and timely implementation of CAPA's
Lead or provide input in process improvement initiatives
Support onboarding of new hires and coordinate workshops, trainings and lessons learned on local and Northern European cluster level
Perform impact assessments of new/revised local regulations and provide clear and timely guidance to the teams
Support in local supplier assessments, assist with annual due diligence update, certification and training of local suppliers
Co-host cluster and regional compliance meetings
Requirements
BA/BS degree in Life Sciences or related scientific field (or minimum 4 years equivalent experience)
A minimum of 3 years of previous pharmaceutical industry experience is required with at least 2 years of GxP experience within clinical research and/or quality assurance
Experience in phase 1, 2, 3 clinical trials is a plus
Good working knowledge and proven understanding of GCP, local laws, and regulations
Developed knowledge of business processes and practices
Ability to present in a clear and concise way - strong communication skills
Strong interpersonal and negotiation skills and ability to empower colleagues and stakeholders
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