We've got a gre at opportunity for a Director of Quality Assurance to join our client . The role suits a senior QA professional, with a background in Quality Management and compliance around the pharmaceutical industry, healthcare research or clinical research organisation or similar background  with a strong understanding of ICH GCP.

We may be able to consider a contractor for this role too. 

Does this sound like you? Please contact us for more information, if it does? 02089850565

• You thrive on challenges and enjoy implementing change, with a particular focus on transforming business quality management systems
• Enjoy working in a fast-paced and innovative environment where you are establishing processes, SOPs and training teams
• You have great 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
• 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) as well as medical research regulation including a thorough knowledge of GCP, 21 CFR and FDA and ABPI and BHBIA requirements
• Operated at a senior management level
• The ability to manage multiple priorities in a changing environment

The role will be very varied, based on business needs,as well as your strategic direction:

• Lead the regulated quality approach
• Enhance current systems and implement required changes to working practices to ensure

  QMS processes are part of organisational DNA

• Ensure the control, coordination, planning and continuous improvement of systems and processes to ensure projects follow required Good Clinical Practice (GCP) and QMS rigour
• Develop and maintain the appropriate Quality Plan and Manual
• Maintain and manage required Standard Operating Procedures (SOPs)
• Support the Information Security Officer (ISO) in quality best practices and approaches including the systems development lifecycle (SDLC)
• Monitor and support the quality processes of individual practices that work to accredited standards (e.g. ISO compliance)
• Maintain existing accreditations as well as lead extension of new accreditations if appropriate
• Centrally s ponsor and lead QMS and input into strategy development
• You will be responsible for leading and/or supporting the external and internal auditing activities and plans (limited travel)

What you will bring:

Strong experience of working in a senior quality role in healthcare research, Pharma, agency or a clinical research organisation

Experience of setting up and running QMS in the Pharma, CRO or life science environment

Strong leadership skills and experience of creating change

Excellent communication and relationship building skills (verbal and written)

A flexible attitude, self-motivated and an ability to work independently and the ability to engage stakeholders internally and at client's too

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

Contact Gail or Henry for more information. +442089850565

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