Quality Assurance Manager, Genedata, CH-Basel

 

The Position

As Quality Assurance Manager your responsibilities are to ensure GMP-compliant software development processes for the business units. The position is supporting the business units in compliance, GxP, data privacy and security-related questions as well as supporting customer audits.

This full-time position is located at our headquarter office in Basel, Switzerland.

Key Responsibilities

Primary duties include, but are not limited to:

  • Execution and management of all QA-related activities for business units
  • Supporting the creation and maintenance of quality documents (SOPs, Policies, Processes, and Templates) as well as security-related documentation (e.g. Security Design Specification) for Genedata products
  • Training of Genedata staff on compliance-related topics (GxP, 21CFR Part11, GAMP5, GDPR, CCPA)
  • Support of authority inspections, vendor audits
  • Support the Implementation of the Genedata QMS within Genedata
  • Provide software validation consulting services to customers as needed to accelerate the software rollout processes
  • Support the continuous improvement goals for the business units and spread the mindset between business units of Genedata

 

Your Profile

  • Educational level: BSc or equivalent in Computer Science. Basic degree in scientific or relevant discipline
  • 3-5 years of experience in the field of Quality Assurance
  • Experience in pharmaceutical and IT industries is required                                
  • Knowledge of GxP, 21 CFR Part 11 and other regulatory requirements for computerized systems, as well as application security
  • Fluent English, knowledge of German is a plus
  • Excellent communication skills

The Company

Genedata is an exceptional company. With over two decades of success in research informatics due to closely-knit teams of scientists, developers and business experts, Genedata has achieved steady and continuous growth since inception. As a private and majority employee-owned organization, we empower each employee to be a contributing voice in the company operations and evolution. Our collective expertise in research informatics, combined with our open and scalable computational solutions, makes us the leading software provider in R&D informatics for biotech, pharmaceuticals, and related life sciences. We are headquartered in Basel, Switzerland and have subsidiaries in Germany, US, UK, Japan and Singapore.

Are You Interested?

If you are interested in this position, please submit us your CV and motivation letter.

Genedata is an Equal Opportunity Employer.

Genedata only accepts CVs and resumes directly from candidates. Personnel recruitment agencies need not respond.