Quality Assurance Manager – Life Sciences
Salary: £70,000k - £80,000k
Type: Full time permanent
Location: Manchester / M62 / North West
UK locations + travel to USA sites
Pharmaceutical Manufacturing
Sector: Pharmaceuticals / Life science supply chain, laboratories, warehouse, logistics, cold storage & distribution
This is an excellent opportunity to join a global pharmaceuticals organisation in a Quality Assurance Manager appointment. You will have responsibly for several large pharmaceuticals and NHS contracts, ensuring laboratories / site storage and logistics Quality Management Systems KPI’s are achieved + be the main point of contact for customers internal & external.
Key Areas: -
* 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)
* Science-based degree discipline
* UK and International travel to USA sites requirment with this role
The key responsibilities: -
* 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.
* Support and deliver services to the portfolio of customers from the life Science / pharma sector
* Facilitate the natural expansion of the business by conducting Supply Chain Mapping analyses and developing customer plans by supporting with the design and development of solutions for new business ventures aimed at achieving business contract growth.
* Showcase strong leadership in people by providing coaching, mentoring, and developing team members.
* Customer Service – Responsible for the delivery of a high standard of Customer Service against agreed targets.
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