We are looking for a QA & RA Director to Biovica, a Swedish biotech company founded in 2009 with a vision to improve monitoring and predicting the efficacy of cancer therapies. The company develops biomarker assays to evaluate the aggressiveness of a cancer disease and monitor the patient’s response to therapy. The initial focus is breast cancer, a disease responsible for over 685,000 deaths a year. Biovica work with leading cancer institutes and pharmaceutical companies on product development with the aim of improving outcomes and lowering costs.
Biovica is in commercialization phase, with a 510(k)-cleared product, launched on key markets with focus on the US market and the Biovica CLIA and CAP accredited laboratory. As the QA / RA Director you are responsible for the company’s QMS and to ensure that quality system requirements are effectively established and documented. To succeed in the role, you also need to be flexible, initiative-taking and risk/benefit balanced. The QA/RA Director reports to the Chief Operating Officer.
The QA responsibility:
Lead and delegate work related to the QMS and quality.
Ensure that quality system requirements are effectively established, documented.
Plan and perform internal audits of QMS processes and suppliers.
Lead and work with risk management in the QMS and development projects.
Lead or support in the validation of processes in the QMS.
Review of promotional, marketing materials.
The RA responsibility:
Ensuring the promotion and awareness of applicable regulatory requirements, customer requirements and quality management system throughout the company.
To plan perform and document management reviews.
Periodic Registration and Device Listing.
Relevant academic degree.
+5 years’ experience as a Quality Manager or similar in life science company (preferably from both larger and smaller sized company) and IVD assays.
+10 years’ work experience of QMS in an ISO 13485, FDA GMP regulated IVD or medical device industry setting.
Knowledge, including documented training with ISO13485, ISO 14971, 21 CFR 820, IVDR or other IVD, MDR/MDD regulations.
Documented internal training within assigned area (e.g., batch records, CC, CAPA, deviations).
As a person you are pragmatic and solution-oriented with a good sense of service and understanding of product and customer needs.
You have excellent organization and communication skills with fluency in written and spoken English.
You are able to work independently as well as cross-functional and to drive things to the goal.
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