Quality Lead

Company –

Scienta are proud to be teaming up with an outstanding BioPharma focusing on the research into Oncology & Infectious diseases (Drug development, manufacturing…etc). Based within the heart of Switzerland this role offers and outstanding opportunity for someone looking to relocate/take on a new challenge.

Our client is now looking for a Quality Lead to expand on the already industry leading team. The position is an exempt level one which is sure to expand your knowledge and experience in the areas of risk management, quality management, quality regulations etc.

Responsibilities –

This position enables a wide range of skills be tested/excelled, all of which fall under the regulatory standards within ICH-GCP. The main requirements are as follows –

• Experience developing a “Risk Based” compliance programme in relation to eCTD Module 5.
• Contribution towards the qualification of CRO/Vendors for the Clinical.
• Collaborating cross functionally with Clinical Trial Managers/Stakeholders to push a Quality mindset and ensure Quality Compliance.
• Acting as the internal Point of Contact for any compliance/regulatory clinical queries.
• Providing Auditing/CAPA support relating to the execution of the Master Auditing plan, alongside ensuring proper CAPA formulation/follow up.

Your Profile –

• A degree within Sciences or Relevant academic backgrounds.
• 5+ years of relevant Clinical Quality experience – Pharma background required.
• Excellent knowledge of GCP, 21 CFR
• Vendor Management experience
• Fluency in English, French is an Asset (Not required)

If you believe that your skill set would be a good match to the requirements above, click Apply now. Or alternatively, email your CV and availability for a 30-minute call to –