Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 trial within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
As a GMP/GDP Quality Assurance (QA) Director, you are responsible to ensure that our global Quality Management System (QMS), processes, and procedures required in the manufacture of investigational medicinal products and medicinal products for commercial distribution are established, maintained and continuously improved in compliance with applicable laws and regulations.
You will control, verify and decide whether manufactured investigational medicinal products or medicinal products for commercial distribution are fit for intended use and that established product requirements are adhered to.
The GMP/GDP QA Director is responsible to assure a satisfactory state of control and compliance with our QMS, manufacturing licenses, marketing and clinical trials authorizations, and other applicable permits and regulatory authorizations. You will actively identify and communicate compliance issues or risks, develop and oversee action plans to rectify such issues or mitigate risks.
Office based and ability to travel up to 25% of time
Education and experience requirements
- Bachelor or master’s degree in relevant applied sciences, e.g. pharmacy, medicine, chemistry, biology and/or engineering (pharmaceutical, chemical or biotechnology).
- 10+ years working experience in quality management, assurance or control, regulatory affairs, product or process development and/or manufacture of medicinal products or other life-science related industry (e.g. medical devices).
- Significant experiences in risk management/quality risk management, quality control, quality assurance and product release processes.
- Significant experiences in quality and compliance management and collaboration with external organizations, e.g. suppliers of goods and services.
- Experiences in handling product complaint, incidents and recalls of distributed medicinal products.
- Experiences in implementation and management of computerized systems.
- Experiences in preparation for, hosting and responding to questions from auditors and reviewers from licensees, notified bodies and/or authorities relating to medicinal products.
- Lead auditor experiences (internal or external) and experiences within quality management of commercial operations, clinical and preclinical development is highly advantageous.
- High skills) in and comfortable in using English and Swedish as written and spoken business language internally and externally.
Reasons to join the Calliditas Team
- Be a part of a global leader in IgA- Nephropathy and a rapidly growing clinical-stage pharmaceutical company
- Be a part of the completion of the Nefegard trial and our focus to file for approval with the FDA and EMA
- Get in on bonus and benefit programs
- Fast paced small company environment
Welcome to join the Calliditas Team!