At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
In Italy, Janssen is looking for a Local Compliance Manager to join the team based in Cologno Monzese.
In this role you will have a dual reporting line into the Local GCO Head and Regional Compliance Leader, and you will be a member of the regional Compliance team.
Your responsibility will be performing activities within the assigned country that ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and you will ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.
Quality and Compliance Oversight Activities:
- Supervise compliance risk and ensure mitigation/remediation actions are defined
- Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or 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 Quarterly Quality Reviews with local GCO (Global Clinical Operations) 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
- Initiate and lead continuous improvement initiatives that show proven impact to the business and processes
- Develop and handle local procedural documents
Local Onboarding and Consultation
- Lead local workshops to support compliance awareness, Lessons Learned, etc
- Provide advice regarding SOP, system and GCP questions. SME in most areas.
- Go to person for handling risk at the country level, including assessing root causes and developing effective actions to mitigate risk.
Local regulatory intelligence:
- Perform impact assessments of new/revised local regulations, guidance, mentorship and Standards ensuring local intelligence is up to date
Collaboration with Business Quality
- Support LOC Management Review in collaboration with LOC Business Quality partners
- Support local supplier assessments as appropriate
- Coordinate annual Due Diligence update, certification, and training of local suppliers People Leadership
- May lead a small number of employees and/or contractors
Education and Experience Requirements:
- Scientific academic background (University)
- A minimum of 6 years of previous Pharmaceutical Industry experience is required, with at least 3-4 years of GxP experience within clinical research and development and/or quality assurance
- Excellent knowledge of English is required (B2 level and above)
- Knowledge of the overall drug development process
- Well-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 is an asset
- Ability to independently plan, organize, coordinate, lead and complete assigned tasks
- Excellent solid understanding of FDA/ICH and country-specific regulations and guidelines related to clinical development
- Must have strong personal leadership skills with demonstrated competency working with all levels of the organization including senior leadership
- Experience in R&D process requirements to successfully drive GCO Compliance efficiency, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
- 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.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.