Manager, Healthcare Compliance and Quality Assurance

BeiGene; Castel del Piano; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A biotech company in Toscana is seeking a Regulatory Affairs professional responsible for ensuring adherence to compliance standards. The role includes managing healthcare compliance projects, driving continuous improvement initiatives, and developing training programs. Candidates should have over 5 years of experience in Regulatory Affairs and fluency in Italian. This position offers an opportunity to impact cancer treatment efforts while collaborating across teams.

Competenze

• 5+ years of experience in Regulatory Affairs.
• Knowledge of privacy topics is a plus.
• Ability to work independently and manage multiple priorities.
• Strong organizational and communication skills.

Mansioni

• Ensure adherence to industry standards and regulations.
• Review and approve healthcare compliance projects.
• Drive continuous improvement in processes.
• Manage corrective actions and risk mitigation strategies.
• Develop training programs on healthcare compliance.

Conoscenze

Analytical skills

Interpersonal skills

Organizational skills

Effective communication

Fluent Italian

Good English

Formazione

University degree in life science / pharmacy / MD / legal

Strumenti

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Veeva systems

Descrizione del lavoro

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 healthcare compliance processes, 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.

In this role, there will be no GMP and GCP activities. No manufacturing.

Essential Functions of the Job:

Key Operational tasks:

• Healthcare Compliance: Be the internal contact for reviewing and approving healthcare compliance projects (such as congresses, sponsorships, market research, consultancy services, advisory boards)
• Healthcare Compliance: Work cross-functionally at local and central level to discuss in advance healthcare compliance topics/issues
• Healthcare Compliance: Be part of the Transparency of Value internal team and support the Manager for the Farmindustria certification
• Healthcare Compliance: Support the Manager in detecting possible privacy topics/issues to be escalated to Global Privacy Team
• Quality Assurance: 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

General tasks:

• Procedural System: focus on developing, implementing, and managing the company's procedural system, 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 the Sr. Regulatory Affairs 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 (GxP and non-GxP processes)
• Corrective Actions: manage the CAPA system, including root cause analysis and ensuring timely completion of corrective and preventive actions (GxP and non-GxP processes)
• Training and Documentation: develop training programs for employees in particular on healthcare compliance topics and ensure proper documentation is maintained
• Support the Manager in providing regular updates on local market trends and best practices about healthcare compliance and quality assurance 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

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

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

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.