EMEA Quality & Compliance Manager

Job type: Mon - Fri, 8 - 5

Location: Fully remote - Regular travel and overnight stays will be required throughout the EMEA region

Salary: Circa £65,000 + Package

Main Responsibilities:

* Developing Quality and Compliance programs, support their implementation and provide training throughout the EMEA account region

* Responsible for general Quality and Compliance on the EMEA account, ensuring all quality matters including change controls, documentation, processes, deviations or customer complaints are investigated and managed

* Support mobilisation of new sites from a quality and compliance perspective

* Review due diligence reports highlighting specific quality and compliance issues

* Develop and roll out resources in order to ensure full compliance with relevant quality management system (QMS)

* Manage the electronic Quality Management System for the client in EMEA

* Conduct training in GxP, QMS and compliance topics, to the wider account operations team

* Execute various processes (e.g. QMS / documentation control, change control, risk management, non-conformance and CAPA management, 3rd party management) in compliance to relevant standards and in agreement with the MSA and Quality Agreements

* Perform trending and analysis of quality and compliance data, KPIs / Intergrade Performance data for continuous improvement opportunities

* Produce monthly reports to regional management teams highlighting successes and hot spots

* Successful client and regulatory audits of GxP activities across the EMEA region

* Timely reporting and investigation of quality related incidents and audits

* Added value to the business through implementing efficient, standardised systems and processes

Candidate Profile:

Essential:

* Solid grounding and practical experience in working in the pharmaceutical or life sciences environment, particularly in a quality, laboratory or facilities management team

* In-depth knowledge of working in a pharmaceutical regulated (GxP) environment, and the standards which must be met to assure patient safety and product quality

* Strong background in quality management and auditing

* Competency to systematically gather information from a variety of sources, analyse information, identify implications of data, draw appropriate conclusions, generate viable alternative solutions to a question or problem and have the ability to apply quality risk management processes to evaluate the consequences of choosing each alternative

* The candidate must have an engaging communication style in order to successfully deliver Quality Compliance and GxP topics or training across the region

* Experience of working with multinational teams specifically across different geographic regions

Desirable:

* Previous experience of working in a large, complex organization and with a global client team

* Extensive experience of having operated successfully in an outsourced B2B environment

Other European languages are advantageous