BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently four drug candidates in five ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. The Company’s validated, proprietary F.I.R.S.T™ technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.
The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit. More information is available at www.bioinvent.com. Follow on Twitter: @BioInvent.
The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development.
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it – as our Director of QA - at our head office in Lund. In this role you will have 6 direct reports within QA and QP. You will be part of the Technical operations leadership term and report to our COO.
Key responsibilities include but are not limited to:
· Qualify leadership within the cross-functional teams
· Maintaining a QMS in compliance with GxP regulations with a scope suitable for BioInvent´s business areas
· Monitoring and inspecting BioInvent’s compliance to the QMS
· Reporting QMS status and quality issues to Senior Management
· Ensuring an escalation process to Senior Management exists for quality issues
· Ensuring BioInvent has a manufacturing licence
· Ensuring the QA team has resources with suitable competence to
- maintain and develop the QMS
- represent QA in the QMS processes
- represent QA in BioInvent Operations GxP activities
· Ensuring QA staff are appropriately trained
· Ensuring Governing documents and training curricula are implemented for QMS processes that QA is responsible for
· Ensuring QA comply with QMS processes
· Maintaining, implementing, developing, and improving the BioInvent’s QMS
· Ensuring BioInvent’s products and clinical trials meet relevant quality standards
· Ensuring BioInvent is audit ready
The assignments also include:
• Represent QA in clinical development/investigational medicinal product and investment projects.
• Support business with QMS processes e.g., data integrity, change control, CAPAs, deviations, complaints, Governing Documents.
• Support operations with selection, qualification, and oversight of GxP suppliers.
• Assess and approve validation plans, records, and reports.
• Plan/perform/lead investigations as required internally and externally.
• Support operational process-improvement efforts
You have a University degree in natural sciences/engineering/quality management or equivalent. You possess an in depth-knowledge in relevant GxP area(s) and have at least 10 years’ experience from the biotech and/or pharmaceutical industry in a GxP compliant environment. You have some years’ experience of personel and budget responsibility. You are fluent in English, written and spoken, as well as in a Scandinavian language. You have experience in development of maintenance of electronic Quality Management system (such as Veeva Vault). Preferably you also have experience in biologics manufacturing in a premarket environment.
As a person we think you are pragmatic, taking responsibility and giving support when needed. You are diplomatic and possess good communications and cooperations skills. Your management lead is a combination of both strategic and operational mindset.
You will be part of a positive journey where we bring antibodies to life. Our primary goal is to develop next generation immuno-oncology drugs with a focus on improving therapeutic results in areas with significant unmet need.
This is a full time position, based at our office in Lund.
In this process we work with Agardh Recruitment & Consulting. If you have any questions you are welcome to contact Pernilla Agardh at 072-249 94 80 or email@example.com. We will evaluate and interview on an ongoing basis and hire as soon as we have the right candidate. Please apply no later than 5th of January.
Welcome with your application!