EMEA Quality & Compliance Manager

Invictus Group; East Midlands; Remote; GBP 65,000

Job description

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:

1. Developing Quality and Compliance programs, support their implementation and provide training throughout the EMEA account region.
2. 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.
3. Support mobilisation of new sites from a quality and compliance perspective.
4. Review due diligence reports highlighting specific quality and compliance issues.
5. Develop and roll out resources in order to ensure full compliance with relevant quality management system (QMS).
6. Manage the electronic Quality Management System for the client in EMEA.
7. Conduct training in GxP, QMS and compliance topics, to the wider account operations team.
8. 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.
9. Perform trending and analysis of quality and compliance data, KPIs / Intergrade Performance data for continuous improvement opportunities.
10. Produce monthly reports to regional management teams highlighting successes and hot spots.
11. Successful client and regulatory audits of GxP activities across the EMEA region.
12. Timely reporting and investigation of quality related incidents and audits.
13. Added value to the business through implementing efficient, standardised systems and processes.

Candidate Profile:
Essential:

1. Solid grounding and practical experience in working in the pharmaceutical or life sciences environment, particularly in a quality, laboratory or facilities management team.
2. 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.
3. Strong background in quality management and auditing.
4. 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.
5. The candidate must have an engaging communication style in order to successfully deliver Quality Compliance and GxP topics or training across the region.
6. Experience of working with multinational teams specifically across different geographic regions.

Desirable:

1. Previous experience of working in a large, complex organization and with a global client team.
2. Extensive experience of having operated successfully in an outsourced B2B environment.
3. Other European languages are advantageous.