Reference Number: JO-1911-440833
Senior Director Clinical Quality Assurance
Job Type: Permanent
Location: Welwyn Garden City
Senior Director, Clinical QA
Salary details available on discussion + excellent benefits package
My client are a leading global pharmaceutical company based in Hertfordshire who are currently seeking an experienced Senior Director, Clinical QA to join their business on a permanent working basis. The company have over 10,000 employees globally and currently have a real focus on two therapy areas with a number of exciting products.
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 progression opportunities and the opportunity to be part of the global Clinical QA senior leadership team with commercial and operational oversight, now really is the time to get in contact to explore further.
The role will be responsible for directly line managing the UK CQA department 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 CQA strategy including audit and inspection management, QMS management, GCP and PV oversight and lead on the assurance of compliance for all projects, products and programs. PLEASE NOTE: This role will require up to 25% travel globally.
Other key responsibilities will include:
Development and execution of QA strategy, audit program (to include; site, vendor, process, systems, regulatory submission, clinical trial documents, directed and for cause audits) across GXP.
Promote proactive, continuous quality improvements, lead strategic and proactive thinking as well as provision of strong input and guidance to situations that arise that require in-depth knowledge of SOPs, GCP and PV regulations and guidelines globally.
Drive interactions with global QA colleagues at other locations to ensure consistency in the application of the QA strategy and to promote standardisation of the auditing approach within QA.
Effective leadership of complex, large-scale CQA initiatives with significant business impact with minimal oversight, provide training and mentorship to less experienced CQA staff and develop and deliver awareness sessions on various GCP and PV topics both internally and externally.
Successful applicants must be able to demonstrate management experience as well as strong understanding of pharmaceutical QA, GCP and PV 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 and PV guidelines and regulations.
Fluent English communications skills (written & spoken).
Ability to interpret complex data and present key findings.
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 email@example.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.