Pharmaceuticals

Associate Director

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About the job

  • UK

Do you have 10+ years of experience working as a Quality professional within the Pharma or Biotech industries, as well as 3+ years leading regulatory inspections and/or audits within the pharma or biotech industries? Are you looking for a new career opportunity?

Invenia Group is pleased to be working with a tier 1 global biotech organization that specializes in cell & gene therapy for oncology, hematology, immunology, and cardiovascular disease treatment. Due to continued growth and expansion, this organization is looking to hire an Associate Director within GCP Inspection Management.

This role will be an office-based position working at their offices in Boudry, Switzerland permanently. Please note you must have EU citizenship for this position.

Role responsibilities: 

The successful person will be an inspection lead for high-risk product submissions and provide inspection readiness duties. You will conduct examinations that calculate the risk of upcoming inspections to the organization’s quality readiness efforts and ensure business readiness from all relevant stakeholders regarding anticipated GCP inspections.

You will also create documents for mock inspections and prepare storyboards to ensure business readiness and ensure all Good Clinical Practise inspections are tracked and entered into the organization’s Quality Management System, as well as lead key regulatory agency inspections for high-risk impact on the organization.

What we are looking for: 

We are looking for a fluent English speaker with higher education within a life sciences organization. You should have 10+ years of experience working as a Quality professional within the Pharma or Biotech industries, as well as 3+ years leading regulatory inspections and/or audits within the pharma or biotech industries.

You should ideally have some experience of cell and/or gene therapy within a GLP environment, and a thorough understanding of QA, including Quality Risk Management, QbD (Quality by Design); and how to identify/escalate risk to the business.

Does this sound like you? To find out more information regarding this opportunity, please apply.