Quality Assurance Manager

Vor 3 Tagen

Basel, Schweiz Genedata Vollzeit

Genedata transforms data into intelligence with innovative software solutions that incorporate extensive biopharma R&D domain knowledge. Multinational biopharmaceutical organizations and cutting-edge biotechs around the globe rely on Genedata to digitalize and automate data-rich and complex R&D processes. From early discovery all the way to the clinic, Genedata solutions help maximize the ROI in R&D expenditure. Founded in 1997, Genedata is headquartered in Basel, Switzerland with additional offices in Boston, London, Munich, San Francisco, Singapore, and Tokyo.

**About the Role**:
As a Quality Assurance Manager, you consult on and implement GxP-compliant software development and service delivery processes, support pre
- and post-sales teams from requirements specification projects to successful software solution roll-out, and manage/oversee validation and documentation support for our biopharma customers. The QA Manager further supports the business units in compliance, GxP, data privacy and security-related questions as well as in customer audits.

In this position you will help develop and maintain quality standards for highly successful scientific software platforms that our customers increasingly use in critical processes for the discovery and development of new medicines.

**Your Responsibilities**:

- Execution and management of all QA-related activities for Genedata’s 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
- Supporting the customer-facing teams with quality-related enquiries and requirements
- Training of Genedata staff on compliance-related topics (GxP, 21CFR Part11, GAMP5, GDPR, CCPA, etc.)
- Support of authority inspections, vendor audits
- Support the Implementation of the Genedata QMS within company and/or business units
- 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

**Skills & Experience**:

- Educational level: BSc or equivalent in Computer Science or a Natural Science
- 2 - 5 years of experience in the field of Quality Assurance, of which at least 1 year experience in computer systems validation
- Experience in the pharmaceutical industry is highly desired
- Computer literacy and an aptitude for computer systems is a must
- Fluent English, knowledge of German is a plus
- Excellent communication skills

**What We Offer**:
Genedata is on a mission to accelerate the pace of biopharma R&D. Our enterprise software solutions digitalize and automate lab operations so scientists can discover insights faster, push scientific boundaries farther, and drive change right now. With over two decades of success due to closely-knit teams of scientists, software engineers, and business experts, Genedata has become the market-leading provider of enterprise software solutions for biopharma R&D.

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 scientific R&D informatics, combined with our open and scalable software platform, makes us the essential technology for the operations of top biopharma companies and innovative biotechs worldwide.

We are headquartered in Basel, Switzerland and have subsidiaries in the US, Germany, UK, Japan, and Singapore.

Genedata offers an attractive Total Reward Package comprised of a competitive salary and attractive benefits in return for your contribution to our success.

As an equal opportunity employer, Genedata proudly celebrates diversity and believes in an inclusive workplace.

**Next Steps**:
If you are interested in this position, please apply

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