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Compliance Management Lead

2 months ago

Honolulu, Hawaii, United States J&J Family of Companies Full time
Job Summary

We are seeking a highly skilled Compliance Management Lead to join our team at J&J Family of Companies. As a key member of our organization, you will be responsible for overseeing and managing our compliance monitoring process, ensuring adherence to relevant laws, regulations, industry standards, and company policies/procedures.

Key Responsibilities
  1. Compliance Monitoring and Risk Management: Oversee and manage the compliance monitoring process, including metric generation and trending, to ensure adherence to relevant laws, regulations, industry standards, and company policies/procedures.
  2. Audit and Inspection Readiness: Supervise operational and management activities related to audit/inspections, ensuring audit/inspection readiness and compliance with regulatory requirements.
  3. Compliance Program Implementation and Management: Oversee the implementation and management of the compliance program, including risk assessments and compliance monitoring activities.
  4. Data Analysis and Decision Making: Analyze data to make informed decisions and improve existing processes/systems.
  5. Regulatory Compliance Guidance: Provide advice and guidance to Activity Owners and stakeholders on achieving regulatory compliance.
  6. Compliance Monitoring Results Communication: Ensure communication of compliance monitoring results per established procedures.
  7. Internal Investigations and Corrective Actions: Conduct internal investigations into compliance-related issues and develop corrective actions.
  8. Compliance Risk Identification and Mitigation: Identify compliance risks and develop strategies to mitigate them.
  9. Audit and Inspection Support: Establish processes related to audit/inspection readiness and support audit/inspection conduct.
  10. Compliance Monitoring System Improvement: Continually improve compliance monitoring systems and processes.
  11. Compliance-Related Policy and Procedure Development: Develop, update, and maintain compliance-related policies and procedures.
  12. Team Development and Performance Management: Provide training and development opportunities to team members, set performance expectations, and conduct performance evaluations.
  13. Team Culture and Collaboration: Foster a positive team culture and encourage collaboration.
  14. Effective Communication: Facilitate effective communication within the team and between relevant functions.
  15. Additional Responsibilities: Perform related duties as assigned by supervisor and maintain compliance with all company policies and procedures.
Qualifications

We are looking for a highly qualified individual with a minimum of a Bachelor's or equivalent University degree, with a focus in Science, Engineering, or technical subjects preferred.

  • Minimum of 8 years pharma experience and 5 years in a management role.
  • Extensive experience in compliance management.
  • Strong knowledge of relevant laws, regulations, and industry standards.
  • Excellent understanding of risk management principles and practices.
  • Strong leadership and people management skills.
  • Excellent verbal and written communication skills.
  • Excellent computer proficiency (e.g., MS Office, SAP).
  • Excellent analytical skills to identify gaps and develop solutions.
  • Ability to work independently with minimum supervision.

This position may require up to 10% domestic & international travel.