Compliance Manager overseeing United Rotorcraft’s compliance initiatives with federal standards. Ensuring audit readiness and managing supplier compliance and training programs.
About the role
- 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
- Proficient in Dutch and English
Benefits
- Inclusive work environment
- Opportunities for professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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