Janssen Italy - Local Compliance Manager

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. We have 40,000 people around the world who show up every day to achieve the unimaginable. This work requires heart, science, and ingenuity. We never stop imagining a future where the most challenging diseases are a thing of the past. In Italy, Janssen is looking for a Local Compliance Manager to join the team based in Cologno Monzese. The Local Compliance Manager has a dual reporting line into the Local GCO Head and Regional Compliance Leader, and is a member of the regional Compliance team. This role is responsible for 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 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: • Monitor compliance risk and ensure mitigation/remediation actions are defined • 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. • 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 • Collaborate with local and central business partners in timely CAPA setting and implementation • Initiate and lead continuous improvement initiatives that show demonstrable impact to the business and processes • Develop and manage local procedural documents Local Onboarding and Consultation • Manage 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 managing 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 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 indirectly lead or supervise employees or 3rd party staff, for small projects/teams Qualifications 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 translate data into information and strategies into executable action plans improving the business • Conflict resolution/management and negotiation skills • Ability to independently plan, organize, coordinate, manage and execute assigned tasks • Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development • Experience with regulatory submissions (NDA, BLA) is an asset • Strong personal leadership skills with demonstrated competency interfacing with all levels of the organization including senior leaders; • Experience in R&D process requirements to successfully drive GCO Compliance productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis • Demonstrated project leadership skills. May serve as a back-up for GCO Regional Compliance Leader At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. Primary Location Italy-Lombardia-Cologno Monzese- Organization Janssen-Cilag S.p.A. (7175) Job Function Quality Requisition ID 2206047137W