Senior Manager Compliance

Position Summary:
This position is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson global processes and procedures.

Acts as a single point of contact for the Cluster/Country, ensuring appropriate and timely communication of significant/critical quality and compliance issues. Participates in process improvement projects, departmental decision-making, recruitment, resource assessments, and end of year performance evaluations.

Responsible for the development of Compliance staff by supporting the development of Human Resources programs including ongoing mentoring, coaching, and training to meet current and future business needs. Provides an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force. Performs administrative tasks associated with recruitment, resource assessments, and end of year performance evaluations.

Principal Responsibilities:
Quality and Compliance Oversight Activities

1. Proactively monitor compliance risk and ensure mitigation/remediation actions are defined.

2. Proactively monitor progress and confirm effectiveness of remediation plans, perform special investigations and plan, prepare, conduct, and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk-based activities:

- 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.

3. Ensure appropriate filing of the QC reports.

4. Conduct Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals. Proactively facilitate in-depth analyses that lead to solutions.

5. Takes a leading role with local and central business partners to facilitate (local) inspections and office audits as needed.

6. Collaborate with local and central business partners in timely CAPA setting and implementation. Leading/Driving global CAPA investigations/mitigations. Seen as an SME for risk management (identification of signals and translating signals into thorough root cause analyses and action to resolve risk, where necessary).

7. Initiate and lead continuous improvement initiatives that show demonstrable impact to the business and processes.

8. Develop and manage local procedural documents, with multi-functional scope, where applicable.

9. Process ownership for GCO Compliance specific procedures and active in continuous improvement and training.

Local Onboarding and Consultation

10. Support onboarding of new hires and drive/influence onboarding and training best practices globally.

11. Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc.

12. As a universal GCP SME, independently provide advice for complex situations across multi-functional scope regarding SOP, system and GCP questions.

13. If applicable, management and accountability of budget for cost associated with On-Boarding and Training across specified regions and functional areas.

14. Go to person for managing risk at the country level, including assessing root causes, and developing effective actions to mitigate risk.

Local Regulatory Intelligence

15. Perform impact assessments of new/revised local regulations, guidance, and standards.

16. Support central functions in ensuring local intelligence is up to date (e.g., CLRR).

Collaboration with Business Quality

17. Actively support LOC Management Review in collaboration with LOC Commercial Quality partners.

18. Coordinate and/or participate in quality council, if applicable.

19. Ensure appropriate local suppliers’ assessments are performed, if applicable.

20. Coordinate annual Due Diligence update, certification, and training of local suppliers, if applicable.

People Leadership (if applicable)

21. Actively contributes to intra and interdepartmental process improvements liaising with the

22. Build GCO Compliance team, identify, develop, and retain talent in the team, if applicable.

23. Serve as a mentor for Manager or Specialist levels, across various functions (within department and outside of immediate department).

24. May directly or indirectly lead or supervise employees or 3rd party staff, for moderate-size programs/projects/teams.

Principal Relationships:
Reports into the Director Compliance REGION as applicable and has a dotted line to the Assoc Director/ Sr Manager/ Director/ Sr Directo