Senior Director GDP Operational Quality

My client is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. They currently have three approved medicines that treat the underlying cause of cystic fibrosis and have several ongoing clinical and research programs in CF.

They also have a robust pipeline of investigational medicines in other serious diseases such as sickle cell disease and kidney disease.

My client is currently looking for a Senior Director in GDP Quality to be based in their London office to oversee International Operations.

They are looking for someone with cell & gene therapy as well as strong technical (QP) and leadership experience. It will be looking after the team and all their affiliates. Looking after the complete strategic quality side thus a strong technical experience is needed.

Job Title: Senior Director, GDP Operational Quality

Salary: £140,000 + plus 25 per cent bonus, stock options, car allowance (approx. 5k)

Location: London (some remote work.

Key requirements:

• Extensive experience in Distribution practices relevant for the International region
• Experience in Gene and Cell therapy manufacturing and distribution will be critical to setting future strategies to support the organization’s growth and expansion
• Broad and deep global health regulatory agency knowledge and experience across multiple GDP/GMP/PV with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness
• General knowledge in electronic system compliance and GCP/GLP requirements
• Knowledge and demonstrated experience in application of risk-based quality principles (e.g. QbD) in a pharmaceutical environment
• Broad and deep operational and project management knowledge and experience
• Demonstrated strategic planning and execution skills
• Proven ability to design/evolve and /or implement quality strategies and operational planning and oversight in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business model
• Current knowledge of industry trends and best practices- for progressive quality risk management in a regulated environment
• Proven leadership capabilities within multi-level organization  
• Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
• Experience with implementation and execution of program and enterprise risk management, Root Cause Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.

If this opportunity is something of interest to you, please send a copy of your cv to James.fraj@albionryeasscoiates.com