NonStop Consulting

Our client, a prominent organization in the pharmaceutical industry in Switzerland, is seeking a dedicated individual to join their team as a Senior Clinical Quality Assurance Manager. This is a contract position that offers a unique opportunity to work in one of the most pharma-focused countries in the world, surrounded by an international environment. The company has recently released a new drug on the market, underscoring its commitment to innovation in improving healthcare outcomes.

Benefits:
– Engage in impactful work within the clinical research and development field
– Foster your expertise in clinical trial regulatory requirements and industry practices
– Contribute to the adoption of robust clinical trial processes within client/CRO teams

Responsibilities:
* Acting as the primary representative for Clinical Quality Assurance in the context of Clinical Trials
* Collaborating closely with the client’s CRO Clinical Trial Teams throughout all phases of clinical trial activities
* Cultivating expertise in clinical trials autonomously through self-directed learning and participation in relevant courses
* Ensuring adherence to regulatory requirements by providing guidance, addressing inquiries, and participating in discussions on GCP matters
* Advocating for the adoption of robust clinical trial processes and systems within client/CRO teams
* Escalating instances of significant or persistent non-compliance with GxP standards when necessary
* Organizing and conducting training sessions on clinical trial essentials, such as ICH-GCP principles
* Delivering presentations on critical ICH-GCP topics, including audit findings and GCP inspections
* Contributing to the training and mentorship of fellow Clinical Quality Assurance professionals
* Overseeing the creation and management of Quality System documents in alignment with clinical trial standards
* Driving process enhancements and improvements within the Quality Systems framework
* Innovating and refining Clinical Quality Assurance tools and processes to optimize performance
* Collaborating on the development and enhancement of clinical trial electronic systems
* Providing troubleshooting support for client processes and systems as needed
* Leading and managing the preparation, facilitation, and follow-up of inspections conducted by international regulatory authorities
* Steering the elaboration, approval, and monitoring of CAPAs resulting from GCP inspections
* Conducting audits as per the established strategy for the global clinical audit program, encompassing site, vendor, and process audits
* Planning, executing, and reporting on standard and/or intricate audits at the global level
* Overseeing the elaboration, monitoring, and closure of CAPAs resulting from audits

Requirements:
– Bachelor’s degree in (life) sciences or healthcare
– Minimum 5 years of experience in the pharmaceutical industry, with at least 3 years in Quality Assurance within the ICH-GCP environment
– Experienced in Clinical Research & Development and knowledgeable in clinical trial regulatory requirements (ICH-GCP is essential)
– Experience with electronic tools used in clinical trials (e.g., eTMF, ePRO, eSource)
– Experience as a GCP Auditor with the ability to travel at least 25% of the time (non-negotiable)

Do you have any disability or condition that could affect you in the application and interview process? Please feel free to share this information as part of your application, including any necessary adjustments you might need, so we can help make the process easier for you. We assure you this information will not have any negative effect on the interview process outcome.

About NonStop: We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We’re passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting (https://www.nonstopconsulting.com), for more information, to browse all our roles, or to let us know how we can help you.

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