Overview

Reference Number: JO-2002-446471
Head of Quality Assurance
Rate: Negotiable
Job Type: Permanent
Location: Amersham

THE DETAILS
Head of Quality Assurance
Buckinghamshire
Salary details available on discussion

THE COMPANY
My client is a leading global technology solution provider based in Buckinghamshire who are currently seeking an experienced Head of Quality Assurance, to join their business on a permanent working basis. The company have around 400 employees globally and are looking to grow substantially over the coming years through targeted acquisitions and organic growth via business development opportunities.

If you are looking for the opportunity to develop yourself, a team and a department then this could be just the role for you. With excellent internal process improvement opportunities and the chance to be part of the global QA senior leadership team with commercial and operational oversight, now really is the time to get in contact to explore further.

THE ROLE
The role will be responsible for directly line managing the UK, European and US QA departments and will take responsibility for all Quality activities related to the development and progression of said department to include; design, development, delivery and execution of the Global QA strategy including audit and inspection management, QMS management, GCP oversight and lead on the assurance of compliance for all projects, products and programs. PLEASE NOTE: This role will require travel globally.

Other key responsibilities will include:
Facilitating the development, planning and co-ordination of company SOPs and on-going maintenance and revisions.
Ensuring QA involvement is targeted to business needs.
Implement and maintain CAPA and Deviations processes.
Effective leadership of complex, large-scale QA initiatives with significant business impact with minimal oversight, provide training and mentorship to less experienced QA staff and develop and deliver awareness sessions on various GCP and QA topics both internally and externally.
Lead the quality review committee reviewing quality risks and issues, following up any findings with recommended strategies for improvement.
Provide support in the preparation and coordination of inspections by regulatory authorities. Facilitate external client QA audits, mentor and train other staff for audit readiness.
Conduct internal facility and system audits across all company operations. This will include visits to the US and EU offices.
Auditing of vendors and sub-contractors to ensure competence and suitability.
Line manage the UK, US and EU QA departments.
Support formal training programmes by highlighting QA training requirements and act as a trainer on QA issues and regulations.

Successful applicants must be able to demonstrate management experience as well as strong understanding of pharmaceutical QA, GCP and QMS experience within a clinical trial/clinical operations environment ideally as well as experience of both developing audit procedures, to include hosting and conducting across local and global regions.

You must also be able to show:
The ability to establish and maintain effective working relationships with internal and external stakeholders.
Extensive/demonstratable knowledge of clinical pharmaceutical procedures.
Demonstrated knowledge, understanding and application of GCP guidelines and regulations.
Fluent English communications skills (written & spoken).
Ability to interpret complex data and present key findings.

THE PROCESS
To apply for this role, please call Bob Beevers at Clinical Professionals on +44 207 822 1710 or send an updated version of your CV via email to bob@scientificprofessionals.com

If this role is not for you, we do operate a bonus referral scheme should we go on to successfully place someone that you recommend to us so please feel free to share these details within your network.

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