Johnson & Johnson

Lead Compliance Specialist

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Madrid • Spain

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Monitor compliance risk and ensure mitigation/remediation actions are defined
  • Monitor progress and confirm effectiveness of remediation plans
  • Conduct Compliance Monitoring Visits
  • Perform assigned reviews of Trial Master File, training compliance documentation and other checks per CRM Integrated Quality Plan for the trial
  • Planning and execution of local QC checks
  • Support and advise local and central study teams in root cause analysis of significant observations
  • Ensure appropriate filing of the QC reports
  • Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals
  • Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed
  • Collaborate with local and central business partners in timely CAPA setting and implementation
  • Support onboarding of new hires
  • Manage local workshops to support QMS and compliance awareness
  • Provide advice regarding SOP, system and GCP questions of moderate complexity
  • Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk
  • Perform impact assessments of new/revised local regulations, guidance, and standards
  • Support central functions in ensuring local intelligence is up to date
  • Support LOC Management Review in collaboration with LOC Commercial Quality partners
  • Support local suppliers’ assessments as appropriate
  • Support annual Due Diligence update, certification, and training of local suppliers, if applicable

Requirements

  • A minimum of Bachelor Degree in Science (BSc) or Arts (BA) or 5-6 years relevant experience equivalent
  • A minimum of 4 years of previous Pharmaceutical Industry experience is required
  • At least 3 years of GxP experience within clinical research and development and/or quality assurance
  • Knowledge of the overall drug development process
  • Developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
  • Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions
  • Ability to translate data into information and strategies into executable action plans improving the business
  • Ability to motivate professional colleagues and stakeholders
  • Conflict resolution/management and negotiation skills
  • Ability to independently plan, organize, coordinate, manage and execute assigned tasks
  • Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development
  • Experience with regulatory submissions (NDA, BLA) is an asset
  • Excellent knowledge of English is required.
  • Proficient in Microsoft Office applications
Benefits
  • Health insurance
  • Professional development opportunities
Applicant Tracking System Keywords

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

Hard Skills & Tools
GxPquality assuranceclinical researchauditsSOPsregulatory submissionsimpact assessmentsrisk managementdrug development processCAPA
Soft Skills
conflict resolutionnegotiationmotivationplanningorganizationcoordinationexecutioncommunicationadvisingcollaboration
Certifications
Bachelor Degree in Science (BSc)Bachelor Degree in Arts (BA)