We've got a great opportunity for a Director of Quality Assurance to join our client . The role suits a senior QA professional, with a background i n Quality Management and compliance around the pharmaceutical industry , healthcare research or clinical research organisation or similar background. This is a

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You will love this role if you:

• Thrive on challenges and enjoy implementing change, with a particular focus on transforming business quality management systems
• Enjoy working among likeminded professionals in a fast-paced and friendly environment
• Pay attention to the details but always in the context of the strategic direction and requirements of the business
• Enjoy ensuring processes comply with regulated requirements

You will be a success if you have:

• Good experience of implementing Quality Management Systems (QMS) in different environments and cultures
• A sound understanding of the principles of QMS in Pharma (non-interventional and low-interventional studies)
• Experience in implementing and embedding a QMS for software development
• The ability to engender change and embed new practices, ensuring the QMS is adopted or, where applicable, enhanced within the relevant practices or business areas
• An in-depth understanding of medical research regulation including a thorough knowledge of GAMP, SDLC, eCoA and GCP and an understanding of 21 CFR and FDA, ABPI and BHBIA requirements
• Influenced at a senior management level
• An approachable style and a can-do attitude
• Good attention to detail
• The ability to manage multiple priorities in a changing environment

As part of the Legal, Compliance and Quality team, you will be responsible for the following activities:

1. Lead the regulated quality approach across the company and other regulated practice areas
2. Enhance current systems and implement required changes to working practices to ensure

   QMS processes are part of organisational DNA

3. Ensure the control, coordination, planning and continuous improvement of systems and processes to ensure projects follow required Good Clinical Practice (GCP) and QMS rigour
4. Develop and maintain the appropriate Quality Plan and Manual
5. Maintain and manage required Standard Operating Procedures (SOPs)
6. Support the Information Security Officer (ISO) for the client in quality best practices and approaches including the systems development lifecycle (SDLC)
7. Monitor and support the quality processes of individual practices that work to accredited standards (e.g. ISO compliance)
8. Maintain existing accreditations as well as lead extension of new accreditations if appropriate
9. Centrally sponsor and lead QMS and input into strategy development
10. Be responsible for leading and/or supporting the external and internal auditing activities and plans (limited travel)
11. Work collaboratively with colleagues to achieve results
12. Support the healthcare data collection teams in reviewing study methodologies

What you will bring:

• Minimum of 10 years' relevant experience of working in a senior quality role in healthcare research, Pharma, agency or a clinical research organisation
• Sound project management skills and understanding of tools and techniques to deliver
• Experience of setting up and running QMS in the Pharma environment
• Graduate or relevant healthcare qualification
• Strong leadership skills and experience of creating and influencing change
• Excellent communication and relationship building skills (verbal and written)
• Stakeholder management experience, internal and external players
• A flexible attitude, self-motivated and an ability to work independently
• Persuasive, positive and assertive attributes
• Systematic, logical, thorough and precise thinking and execution
• Sound IT skills - knowledge of Word, Excel and PowerPoint as well as QMS

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