Laurent Besson Email & Phone Number

Saint-Aubin, FR, CH

Le Crêt-du-Locle, CH

• Manage the Quality & Regulatory Department organization
• Act as Person Responsible for Regulatory Compliance (PPRC) as defined by Regulation (EU) 2017/745
• Act as Management Representative as defined by ISO 13485
• As a member of the Executive Board, participate to the establishment of the company's strategy and its deployment
• Ensure the continued compliance of the quality management system with applicable regulatory and normative requirements and maintain the corresponding certifications (ISO 13485, CE marking, MDSAP).
• Build quality culture across all levels and functions of the organization

Melbourne, Victoria, AU

• Develop standardized Change Management processes for all CSL sites and functions in close corporation with the Change Control Process Owner.

Raleigh, NC, US

• Support project of adding a new manufacturing site on existing QMS (certified ISO13485 and MDSAP)
• Pilot each department work package and update plan to meet timeline requirement
• Support QA team in the preparation of the future certification onsite audit

Mason, Michigan, US

• Quality Management System remediation plan
• Review and improve CAPA process then management of CAPA system
• Review and improve other Quality system (internal audit, NCR, etc...)
• Support FDA readiness remediation plan
• Support implementation of a new LMS (Learning Management System - ComplianceWire)

Zurich, Zurich, CH

• InnoPark supports qualified specialists and executives in their job search, to ensure their rapid reintegration into the work market, and helps companies to turn their projects or business ideas into reality.Member of.
• Help Start-ups to redefine their business model, strategies, and expansion plan
• Project planning, Project objectives definition, and Resource allocation
• Identify and manage project risks and issues
• Tracking of project effort, milestones, financials
• Ensure adherence to project management standards

Madison, WI, US

• International Quality Department management of the International Region (AIS) comprising EMEA, APAC and Japan
• Provide day-to-day leadership of the Quality Assurance function in support of the AIS business operations
• Dotted-line responsibility to the General Manager of Accuray AIS, and representative of Regulatory, Quality and Compliance in the GM’s staff (European Leadership Team)
• Sit on the Accuray Product Safety Committee as voting member for safety reportability (e.g. MDR, Vigilance, Recall) and non-safety field action decisions
• Determine and establish AIS group goals and objectives aligned with departmental and business goals and priorities
• Inspection Readiness activities (e.g. act as host/interface, and arrange front and backroom logistics), during EIMEA-based inspections with Notified Body, FDA, and international regulatory agencies

• Provide independent, objective advice to organizations on strategies to improve the quality of their products and services

New Brunswick, NJ, US

• Department management, around 20 peoples
• Responsible and accountable for all quality processes (NC,CAPA, Audit, etc…)
• Department budget management
• Quality point of contact and main auditee during external audit (BSI, FDA, etc…)
• Lead of External audit preparation
• Establish Goals and objectives for the Quality department

New Brunswick, NJ, US

• Quality Engineers group management
• Extension lines projects
• Development and introduction of new products on the market, collaboration with R&D.
• Member of the qualified internal auditor team.
• Ensure follow-up of non-conformities
• Release of finished products.

New Brunswick, NJ, US

• QA support for product transfer validation
• QC inspectors training to test methods
• Creation of a GMP course and training production personnel
• QA Representative for computer system validation (CSV)
• Member of the qualified internal auditor team

Basel, Baselstadt, CH

• Management of an inter-service group in charge of complains to suppliers
• Following correctives actions at supplier's site
• Lead project to implement a global quality system with all suppliers
• Suppliers audits
• Participated to the choice of new supplier
• Participated to specification, installation, and validation of a LIMS

Holzminden, Lower Saxony, DE

• Production (12 persons) and samples laboratory (2 persons) management
• Stock rationalization. Cost savings by reducing stock of 10% of total value