EMEA Quality & Compliance Manager

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