Quality Assurance Lead

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Meet Full time
Job Overview

Quality Assurance Lead - based in a dynamic environment

Department Purpose

The Regulatory, Medical, and Quality Affairs Department is tasked with ensuring adherence to regulatory standards, generating technical documentation, and maintaining the quality management systems essential for the development, manufacturing, and distribution of in vitro diagnostic devices.

Role Objective

This senior position is pivotal in steering compliance and enhancing quality within the Quality Management System (QMS) necessary for companion in vitro diagnostic devices, adhering to recognized regulations.

The incumbent will guarantee that the organization meets the requisite quality benchmarks, with a particular emphasis on supplier management, manufacturing protocols, quality assurance, and design oversight. The role is centered on strategic compliance initiatives, technical enhancements, and guiding junior personnel in regulatory protocols.

Key Responsibilities

  • Lead and promote compliance with current Good Manufacturing Practices (cGxP) and continuous quality enhancement strategies across various teams, ensuring alignment with the QMS and related processes for companion diagnostic devices.
  • Collaborate closely with the Operations and Supply Chain teams to implement effective supplier management initiatives.
  • Engage with the precision medicine team to develop quality and compliance strategies that meet the organization’s pharmaceutical business requirements, including readiness for partner audits and regulatory submissions.
  • Establish and implement systematic enhancements to the QMS in accordance with regulatory standards, advocating for best practices in quality and compliance.
  • Work alongside the Executive Vice President of Regulatory, Medical, and Quality Affairs and cross-functional teams to integrate cGxP into standard operating procedures.
  • Serve as a subject matter expert on cGxP implementation, translating compliance requirements into practical, scalable solutions.
  • Facilitate cross-departmental teams in root cause analysis, corrective action planning, and process optimization.
  • Guide junior staff in technical problem-solving, corrective and preventive action (CAPA) implementation, and root cause analysis methodologies.
  • Coordinate both internal and external audits, ensuring effective implementation of corrective actions.
  • Oversee post-market surveillance, vigilance, and risk management processes to comply with regulatory protocols.
  • Report on Key Performance Indicators (KPIs) to the Executive Vice President of Regulatory, Medical, and Quality Affairs.
  • This is a full-time position based on-site, suitable for candidates in the surrounding areas.

Required Qualifications

  • A minimum of 7 years of experience in quality management systems regulated by the FDA, including experience with audits by regulatory bodies, preferably in a molecular diagnostics manufacturing environment.
  • In-depth knowledge of ISO 13485, 21 CFR Part 820, and regulations pertaining to companion diagnostic devices.
  • Proven leadership in compliance strategy, quality enhancement, and project management.
  • Expertise in developing QMS KPIs, audit responses, and technical documentation.
  • Excellent communication skills to foster collaboration and promote adherence to compliance standards.

This position offers an opportunity to contribute significantly to the quality assurance landscape within a forward-thinking organization.



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