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Project Lead Quality Manager

2 months ago

Winsford, Cheshire, United Kingdom Advanced Medical Solutions Full time
About the Role

We are seeking a highly skilled Project Lead Quality Manager to join our team at Advanced Medical Solutions. As a key member of our Group Quality Process Team, you will play a critical role in delivering our Quality Assurance Strategy and aligning with corporate goals and objectives.

Key Responsibilities
  • Lead Validation Activities: Ensure compliance with regulatory requirements through the effective implementation and continuous improvement of our Quality Management System (QMS), with a specific focus on software validation.
  • Collaborate with Cross-Functional Teams: Support the implementation of new systems while ensuring compliance with quality standards.
  • Oversee Continuous Improvement: Focus on validation and software-related procedures to drive quality excellence.
  • Manage CAPA Processes: Ensure timely and effective resolution of quality issues related to validation and software quality.
  • Drive Document Management: Ensure accuracy, accessibility, and compliance with regulatory standards for all relevant documents.
  • Contribute to Project Management: Focus on software projects and ensure quality systems are aligned with project objectives.
  • Collaborate with Audit Stakeholders: Identify areas for improvement and facilitate corrective actions.
  • Ensure Quality Systems Compliance: Ensure our quality systems, including software-related processes, comply with applicable regulations such as GAMP, cGMP, MDSAP, and Medical Device Regulation (MDR).
Requirements
  • Education: Bachelor's degree or equivalent in a scientific discipline or comparable experience in the medical device or pharmaceutical industries.
  • Experience: At least 2 years of experience in medical device or pharmaceutical industries.
  • Skills: Proficiency in applicable Quality System Regulations, ISO quality requirements, and specific regulations like GAMP, 21 CFR Part 11, and Eudralex.
  • Ability to Develop and Implement Quality Improvement Initiatives: Track, analyze, and report on progress and effectiveness.
  • Strong Communication and Presentation Skills: Effective communication with staff, peer groups, etc., across the organization.
  • Proficiency in Microsoft Office: Word, Excel, and PowerPoint for documentation and presentation.
  • Effective Time Management and Task Prioritization: Meet critical deadlines while supporting multiple projects.