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QA Manager
Crosslinks is a small, dynamic company based in Rotterdam that produces software and analytic solutions applied to improving patient diagnostics, especially in the exciting area of applied genomics that is revolutionizing healthcare worldwide. An prime example is our flagship project creating the IT infrastructure powering a novel Leukaemia diagnostic microarray platform. As we have this and other projects ongoing in this area we have an opportunity for an experienced quality manager with responsibility for ensuring that our quality system guarantees the highest-quality solutions that meet the strict safety and compliance standards in this market.
Key responsibilities would be the creation, implementation and monitoring of the manuals and operating procedures for the overall company quality system, plus production and implementation of the validation plans and protocols for specific products. The successful applicant will have demonstrable experience in creation and maintenance of quality systems conforming to standards such as ISO 9001 and 13485 -preferably in the context of developing software systems and testing protocols according to guidelines such as GAMP 5. Specific industry experience in pharmaceuticals/biotech is an advantage but exceptional candidates from other areas will also be considered.
Crosslinks can offer a position with a real opportunity to shape the direction of the organization and your role within it if you have the flexibility and resilience for a small entrepreneurial environment. As such it would suit a self-reliant, hands-on person capable of building up this area and a team to support it within the company. The reward package on offer is competitive and may include stock options for the successful applicant.
Up for this challenge? Please contact us via the contact form…