Johnson & Johnson

Local Compliance Manager

Johnson & Johnson

full-time

Posted on:

Location Type: Office

Location: BeerseBelgium

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About the role

  • Build a local long-term strategically sound quality plan
  • Measure and identify compliance risks and define remediation actions
  • Supervise progress and confirm effectiveness of remediation plans
  • Conduct QC checks on trials and processes
  • Prepare and oversee inspections and audits
  • Manage CAPA's and lead process improvement initiatives
  • Support onboarding of new hires
  • Organize local workshops, trainings, and increase compliance awareness
  • Perform impact assessments of new/revised local regulations
  • Keep local regulatory intelligence up to date
  • Perform local supplier assessments
  • Coordinate annual due diligence update, certification, and training of local suppliers
  • Lead local compliance meetings and global initiatives

Requirements

  • BA/BS degree in Life Sciences or related scientific field (or 8-10 years equivalent experience)
  • Minimum of 6 years of pharmaceutical industry experience
  • At least 4-6 years of GxP experience within clinical research and/or quality assurance
  • Experience in phase 1, 2, 3 clinical trials is a plus
  • Strong understanding of GCP, local laws, and regulations
  • Strong communication skills
  • Strong interpersonal skills
  • Proven project leadership skills
  • Proficient in Dutch, English and French (for Belgian candidates)
Benefits
  • Inclusive work environment
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GxPGCPclinical trialsquality assurancecompliance risk assessmentCAPA managementprocess improvementimpact assessmentsupplier assessmentregulatory intelligence
Soft Skills
communication skillsinterpersonal skillsproject leadershiporganizational skillstraining facilitationworkshop organizationteam managementstrategic planningproblem-solvingcollaboration