Local Compliance Associate Director - Cologno Monzese, Italia - Johnson & Johnson

Johnson & Johnson

Azienda verificata

Cologno Monzese, Italia

1 settimana fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

We are looking for a
Local Compliance Associate Director to join our growing Clinical Operations team in Italy.

In this role you will have the responsibility to ensure our clinical trials are conducted in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.

You will contribute to build and further grow the GCO Compliance team with the strive to optimize ways of working, drive innovation and future readiness.

You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.

Principal Responsibilities:

Quality and Compliance Oversight Activities:

Supervise compliance risk and ensure mitigation/remediation actions are defined; supervise progress and confirm effectiveness of remediation plans
Conduct On-Site Compliance Monitoring Visits
Conduct 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 and collaborate in timely CAPA setting and implementation
Develop and manage local procedural documents
Support onboarding of new hires and drive/influence onboarding and training standard processes globally
As a universal GCP SME, independently provide advice for complex situations across multifunctional scope regarding SOP, system and GCP questions
Perform impact assessments of new/revised local regulations, guidance and standards and support central functions in ensuring local intelligence is up to date
Coordinate local supplier assessments

People Leadership:

Build Local Compliance team: identify, develop and retain talent in the team
Mentor for Manager or Specialist levels, across various functions (within department and outside of immediate department).

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

Qualifications:

Education and Experience Requirements:

A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 810 years experience equivalent is required.
46 years of GxP experience within clinical research and development and/or quality assurance is required.
Extensive knowledge of the overall drug development process
Advanced skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities). Welldeveloped skills working crossfunctionally
Conflict resolution/management and influencing skills
Independently plans, organizes, coordinates, leads and drives assigned tasks
Solid understanding of FDA/ICH and countryspecific regulations and guidelines related to clinical development
Must have strong personal leadership skills with proven competency working with all levels of the organization including senior leadership
Experience in R&D process requirements to successfully drive Q&C efficiency, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
Handles or leads multiple projects, including some considered complex and/or with accelerated priority, beyond immediate country responsibilities in support of regional/global Compliance/GCO projects.

We offer a competitive salary and extensive benefits package.

The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance.

We offer career development opportunities for those who want to grow and be part of our organization. We are Janssen

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.