BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
Under the direction of the Director Regulatory Affairs, Quality Assurance and Compliance Italy, this individual is mainly responsible to ensure the company adheres to industry standards, regulations, and internal policies through activities like developing, implementing and monitoring quality systems, and managing corrective actions.
Key responsibilities include reviewing processes, monitoring compliance, conducting internal monitoring activities, and leading continuous improvement initiatives. This role requires strong analytical skills, meticulous attention to details, and the ability to work cross-functionally and communicate effectively.
Essential Functions of the Job:
Quality system management:
Focus on developing, implementing, and managing the company's quality management system and related policies and procedures according to local laws and requirements and Global/Regional internal documents.
Process Improvement:
Drive continuous improvement by cross-functionally analyzing processes, identifying inefficiencies, and implementing new or revised procedures together with project owners.
Work in strict alignment with Sr. RA Manager to implement and monitor processes related to medical-scientific information.
Risk Management:
Identify and evaluate compliance risks and develop and implement strategies to mitigate them.
Corrective Actions
Manage the CAPA system, including root cause analysis and ensuring timely completion of corrective and preventive actions.
Training and Documentation:
Develop training programs for employees on quality and compliance topics and ensure proper documentation is maintained.
Support the Manager in providing regular updates on local market trends and best practices about compliance and quality environment to local management team and regional compliance/quality team, recommending (if any) necessary actions.
Support the Manager in conducting annual live monitoring exercises on local activities, e.g., local advisory boards, local congresses, in hospital meetings and field interactions, as per Monitoring Plans.
Support the Manager to manage audit and inspections and prepare the involved staff from an inspection readiness point of view.
Operational tasks:
Compliance: be the internal contact for reviewing and approving HCC compliance projects (such as congresses, sponsorships, market research, consultancy services)
Compliance: be part of the Sunshine Act internal team
Compliance: Support the Manager in detecting possible privacy topics/issues to be escalated to Global Privacy Team
Quality: support the Manager in managing GDP tasks (if any), aligning with European and Global colleagues, and managing contacts related to QA topics with the external wholesaler
Supervisory Responsibilities:
No
Computer Skills:
Efficient in Microsoft Word, Excel, PowerPoint and Outlook.
The knowledge of Veeva systems and other compliance approval tools is a plus
Education required:
University degree in life science / pharmacy / MD / legal
Other Qualifications:
5+ years of experience in the Regulatory Affairs .
Knowledge of privacy topics is a plus.
Ability to work independently, handling multiple priorities in a fast-paced environment.
Very good interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization.
Fluent Italian written and spoken.
Very good English written and spoken.
Travel:
Up to 20%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.