Johnson & Johnson is currently seeking an EMEA Director GCO Compliance to join our team to be located in Beerse, Belgium, Milan, Italy, Warsaw, Poland, Hyghyim Wycombe, UK, Issy Les Moulineaux, France, or Kibbutz Shefayim, Israel.
The Regional Compliance Leader is a member of the Regional Compliance Leadership Team as well as the GCO Regional Leadership Team. The Regional Compliance Leader manages and directs the local Compliance Leads and their teams in performing activities within the region to ensure an integrated and comprehensive quality and compliance approach for clinical trials is implemented and maintained.
The Regional Compliance Leader acts as a single point of contact for the region, ensuring appropriate and timely communication of significant/critical quality and compliance issues and making recommendations for improvements to relevant senior level partners. Leads efforts for establishing and implementing regional compliance processes and guidance across the regions. Participates in process improvement projects, departmental decision-making, recruitment, resource assessments, and end of year performance evaluations. Assists R&D; Quality with interdepartmental and cross-regional strategic planning.
**Principal Responsibilities**:
- Directs Compliance staff responsible for implementing and execution of quality and compliance processes in the region in alignment with the R&D; Quality strategy and in close collaboration with leaders in the applicable areas. Such processes include, but are not limited to
- setting and achieving region specific Compliance goals and objectives
- execution of QC checks and activities such as On-Site Compliance Monitoring visits, TMF review, etc. and remediate compliance risk identified through key performance indicators, QC checks and audits/inspections
- report and escalate significant quality issues along with operational reporting per issue escalation procedures
2. Ensures execution of streamlined infrastructural Compliance support activities to Country Operations teams such as
- onboarding of new hires
- provide support before, during and after inspections
- monitoring of new/revised local requirements, maintenance of relevant integral intelligence repositories and impact assessments
- development, implementation and maintenance of focused local procedural documents in line with R&D; Quality guidance
3. Monitors the timely execution of local GCO Quarterly Quality Reviews, documenting the review of (potential) risk and the appropriate mitigation to address this risk. Provide regular summaries to regional GCO leadership team.
4. Provides expert GCP and SOP consultancy and guidance to GCO Compliance staff. Provides advice in CAPA setting after audits and inspection findings. Resolves compliance/regulatory issues with business partners within the region.
5. Actively contributes to intra and interdepartmental process improvements collaborating closely with various functions to continuously improve the clinical processes, systems and training.
6. Recruits/hires qualified staff for the department and ensures they have the appropriate training, education, experience and tools. Provides ongoing mentoring, coaching and development of Compliance staff. Performs administrative tasks associated with recruitment, resource assessments, and end of year performance evaluations. Provides an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force.
**Principal Relationships**:
The Regional Compliance Leader reports into the GCO Global Compliance Leader with a dotted-line reporting into the GCO Head of the Region and supervises a team of Cluster/Country Compliance Leads, Local and Regional Compliance Managers/Specialists as applicable. Is a member of the GCO Compliance Leadership Team and leads the Compliance team.
**Qualifications**:
**Education and Experience Requirements**:
**Education**:
A minimum of a Bachelors Degree or equivalent is required. A minimum of 12 years’ experience in a medium to large scale matrix organization which includes applicable compliance related field and/or equivalent time and experience in a related R&D; area is required. Requires a thorough knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques.
**Related Experience**:
- Experience of the overall drug development process
- Expert knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development
- Extensive knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
- Experience with regulatory submissions
- Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory sub