Quality Assurance Manager - Life Sciences
Salary: £70,000 - £80,000
Type: Full time permanent
Location: Manchester / M62 / North West, with UK locations and travel to USA sites
The company is a global pharmaceuticals organisation, operating in the sector of Pharmaceuticals / Life science supply chain, laboratories, warehouse, logistics, cold storage & distribution.
Job Overview
This is an excellent opportunity to join the company as a Quality Assurance Manager. The successful candidate will be responsible for several large pharmaceuticals and NHS contracts, ensuring laboratories / site storage and logistics Quality Management Systems KPI's are achieved, and will be the main point of contact for customers internal & external.
Key Responsibilities
- Day to day management of the Pharma / Life Science / Laboratories Quality Assurance systems
- Leadership & People management - Team management - mixed teams
- ISO 9001 Quality System requirements experience and standards
- Quality Assurance planning, operations / investigations
- Client audits and regulatory inspections
- Good Clinical Practice (GCP)
Key Areas of Focus
- Day to day site management of the Quality Assurance systems and processes + teams
- Responsible for the maintenance and improvement of quality systems and processes: e.g. Incident management, complaints, supplier approval, validation protocol and report review and approval
- Performing internal audits and study-specific audits for customer compliance
- Reporting findings to appropriate personnel and monitoring progression of actions to ensure prompt completion through the systems
- Hosting client audits and regulatory inspections and the development of responses to subsequent meetings visits
- Maintain up to date knowledge of relevant regulatory requirements
- Being a point of contact for the quality management system and providing guidance and support, where applicable
- Providing training in applicable quality concepts and providing the appropriate quality inductions to new recruits
- Provide staff training in the Quality Management System and the Principles of GMP as appropriate and identifying relevant quality-related training needs
Person Specification
- Previous experience of working within a pharmaceutical supply chain environment
- Experience working with a quality management system
- BSc (or equivalent) science-based
- Previous experience of multi-channel Quality Assurance operation
- UK and International travel to USA is required