David Marchand Email & Phone Number

Billerica, Ma

Responsible for Contract Manufactured finished good supply chain supporting global Bioscience and Biopharmaceutical customers. Contract Manufacturing supplier base ranges throughout North America, Europe and Asia.Responsibilities include supplier qualification/maintenance, product validation, supply chain management, change control management, documentation maintenance, statistical process monitoring with continual improvement activities and supplier compliance audits to ISO 9001, ISO 13485 and 21 CFR part 820 quality system requirements/regulations.Activities include qualifying new suppliers, scheduling/performing periodic supplier assessments, monitoring supplier/product performance, CAPA management, change control for raw materials and contracted finished goods, participating in new product development outsourcing and investigating customer complaints through defect and root cause analysis.

Jaffrey, Nh

Responsible for coordinating and hosting external certification and customer site compliance audits to ISO 9001 and 21 CFR part 820 quality sytem requirements/regulations. Activities include scheduling, coordinating logistics, site preparation, reporting, responding and CAPA initiation/tracking.Also responsible for site Internal Audit program planning, scheduling, auditing, reporting, CAPA initiation/tracking and internal auditor training certification.