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Senior PV Manager (interim) Job

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Date: Oct 2, 2021

Location: Farnham, SRY, GB

Company: Boston Scientific

Purpose

  • Manages all Quality Assurance activities and Quality Systems implementation to facilitate timely support to Boston Scientific country/regional business offices and customer service centers across the region, ensuring the highest level of regulatory compliance in local operations. Participates in and supports the International Business Practices audit process to partner in driving best practice and internal/external compliance at the local level.

Responsibilities

  • Operational Quality: Manages all quality functions within the country/regional office and interacts on a daily basis with local management (e.g. Sales, Marketing, Customer Service, etc.) in all quality related matters; Is the primary point of contact for Complaint Handling at the local level, providing the first level of review for complaint capture and data entry by customer service staff; Is the primary point of contact at the local level for interfacing with the Vigilance responsible(s), when necessary to resolve issues relating to the sufficiency of data capture for potential reportable incidents; Responsible for driving complaint closure through appropriate liaison with responsible CMC/CIS sites for all complaints originating within their country/region; Actively manages local execution of Field Corrective Actions in affected countries; Ensures appropriate level of product traceability is maintained via oversight of inventory management, local warehouse operations, product disposition decisions, etc; Responsible for the delivery of quality and compliance related training to applicable employees at the local level, and for the maintenance of associated training records; Assists the local Sales Management in addressing quality related issues affecting Key Opinion Leaders in a timely manner; Conducts and tracks Country/Regional quality audits in accordance with approved audit schedules; Is the champion for Quality and Compliance at the local level, driving an attitude of continuous improvement.
  • Quality System Compliance: Leads the implementation and management of the BSC Quality System at a local level, by establishing a high level of commitment towards the local quality objectives; Guides the local management team to maintain full compliance with the BSC Quality System, including the Corporate Quality Manual and Standard Operating Procedures; Develops quality awareness in every employee, while guiding the local organization towards improved performance and customer oriented initiatives; Identifies quality system problems, while providing advice and solutions, verifying ultimate implementations of those solutions; Ensures that all the Procedures are in place and the appropriate personnel have been trained on them; Where identified as a local business need, leads the development and implementation of ISO 13485 certification activities, in close coordination with the Regional Quality Systems Manager.
  • Quality Metrics & Communications: Establishes quarterly Management Reviews of Quality, where non-compliances (CAPA�s), associated risks, field actions, internal/external audits and other metrics are reviewed and documented; Shares periodic information across the Regional Quality Team on local issues, with the purpose of soliciting input on best practices and/or seeking consistent solutions to common problems; Responsible for country/regional input into the Corporate Post-Market Surveillance reporting program on a periodic basis; Primary communications channel for quality and compliance issues between the local office and Regional Quality Department/Corporate Quality; Partners with the local Regulatory Affairs Manager to assist in establishing and maintaining a trusted relationship with the local health authorities; Where applicable, and ...

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