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Group Quality Project Lead

2 months ago

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

Advanced Medical Solutions (AMS) is a world-leading independent developer and manufacturer of innovative tissue-healing technology. Our mission is to provide quality outcomes for patients and value for payers through our wide range of surgical products, including tissue adhesives, sutures, haemostats, internal fixation devices, and internal sealants.

Job Details

The purpose of this role is to support the Group Quality Process Team in delivering the Quality Assurance Strategy, aligning with corporate goals and objectives. The role involves ensuring compliance with regulatory requirements through the effective implementation and continuous improvement of the Quality Management System (QMS), with a specific focus on software validation.

Key Responsibilities
  • Lead validation activities for new software systems, ensuring alignment with regulatory requirements.
  • Collaborate with cross-functional teams to support the implementation of new systems while ensuring compliance with quality standards.
  • Oversee continuous improvement of quality processes, with a specific focus on validation and software-related procedures.
  • Manage Corrective and Preventive Action (CAPA) processes related to validation and software quality issues.
  • Drive document management processes, particularly those related to software validation documentation.
  • Ensure accuracy, accessibility, and compliance with regulatory standards for all relevant documents.
  • Contribute to the development and execution of project management activities, with a particular focus on software projects.
  • Collaborate with audit stakeholders to identify areas for improvement and facilitate corrective actions.
  • Ensure quality systems across the AMS Group, with an emphasis on software-related processes, comply with applicable GAMP, cGMP, MDSAP, and Medical Device Regulation (MDR).
  • Lead the development and improvement of the quality management system across the AMS Group with a focus on software validation.
Requirements
  • BS or equivalent in scientific discipline or comparable experience in the medical device or pharmaceutical industries.
  • At least 2 years of experience in medical device or pharmaceutical industries.
  • 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, including tracking, analysing, and reporting on progress and effectiveness.
  • Strong written and oral communication and presentation skills for effective communication with staff, peer groups, etc., across the organisation.
  • Proficiency in Word, Excel, and PowerPoint for documentation and presentation.
  • Effective time management, task prioritisation, and the ability to meet critical deadlines while supporting multiple projects.