Calliditas is a commercial-stage biopharmaceutical company 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. We have our headquarters in Stockholm, Sweden and offices in the USA, Switzerland and France.
Calliditas’ lead product, developed under the name Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO® and conditional marketing authorization by the European Commission under the trade name KINPEYGO®. Additionally, Calliditas is conducting a Phase 2b/3 clinical trial in primary biliary cholangitis and a Phase 2 proof-of-concept trial in head and neck cancer with its NOX inhibitor product candidate, setanaxib.
Calliditas’ common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).
As a Quality Manager Development & Supply you will work in close collaboration with the Quality Assurance unit and Calliditas’ functional heads and process owners leading the research, development and supply of Calliditas’ medicinal substances and medicinal products. The role provides quality management support and expertise to Calliditas’ projects and activities within product and process development, manufacture and supply of medicinal substances and medicinal products to be used in pre-clinical and clinical studies, and commercial distribution.
In the role you are expected to actively identify and communicate quality issues, risks and opportunities, be actively involved in developing, implementing and follow up action plans to rectify issues, mitigate risks and realizes opportunities with respect to the Calliditas medicinal substances, medical products and Calliditas’ quality management system and its processes. Ability to travel to other Calliditas’ affiliates in Switzerland, France and USA as well as engaged suppliers globally is required for the role. You are expected to travel up to 20% in this role.
Tasks and responsibilities
- Support, and as agreed lead, Calliditas’ quality management processes within product and process development, manufacture and supply of medicinal products used in pre-clinical and clinical studies, and as needed supply of commercial medicinal products.
- Support, and as agreed lead, implementation of changes and conducting investigations related to product complaints, issues, deviations, and other findings to identify root causes, corrections, risk mitigations, corrective, or preventive, and/or improvement actions in collaboration with related experts within the field.
- Provide quality management oversight, expertise, support, reviews and as required quality approvals to product and process development, manufacture and supply of investigational medicinal products, and maintenance and supply of commercial medicinal products.
- Provide quality management oversight, expertise, support, reviews and as required quality approvals of:
- Suppliers and other third parties involved in outsourced activities or procured material and services to Calliditas, including development and follow up of quality and service agreements.
- Projects related to product and process development, supply and distribution pf medicinal products used in pre-clinical, clinical studies and commercial supply.
- Computerized systems and other infrastructure within Calliditas group.
- Act as owner of assigned quality management processes and as such drive and ensure their suitability and effectiveness, and continual improvements.
- Ensure appropriate reporting to management, and as applicable other stakeholders, of agreed quality and performance metrics, deliverables issues or risks.
- Support, as applicable, writing, review, and approval of governing documentation such as procedures, methods, protocols, applications and regulatory files.
- Lead by example through ensuring own compliance with Calliditas’ policies, values and procedures as well as promoting own team and wider Calliditas to do so.
- Maintain a contemporary knowledge of current industry trends, standards and methodologies, and specially as it relates to quality management, such as GLP and GMP.
Your profile/ Relevant background
To thrive in this role we think you are a self-motivated and customer focused person who take ownership and act with high integrity and maturity as a leader, willing to learn and adopt a collaborative and coaching approach. We are looking for you that have approximately 10 years working experience in quality management, assurance or control, manufacture, supply chain, regulatory affairs and/or, product and process development of medicinal substances and/or medicinal products. We believe that you have significant working experience working with quality management within discovery, research and development of medicinal substances and medicinal products, their production processes, test methods and related controls. Highly meritorious are experiences within:
- Pre-clinical and clinical operations
- Leading audits and inspections (internal or external)
- Project and process management
- Preparation for, hosting and responding to questions (face-to-face as well as written responses) from auditors and reviewers from competent authorities and/or licensees.
- University degree i.e. a minimum of Bachelor or master's degree in relevant applied sciences, e.g. pharmacy, medicine, chemistry, biology and/or engineering (pharmaceutical, chemical or biotechnology).
- Broad knowledge of EU Regulations, FDA Regulations and ICH Standards related to medicinal substances and medicinal products, and such applicable to discovery, research and development.
- Communicates professionally, clearly, concisely, and consistently both verbally and in writing to internal and external customers 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 commercial-stage pharmaceutical company within specialty products with strong growth ambitions and a strong pipeline
- Fast paced small company environment
- A unique corporate culture
- Dedicated, experienced and highly skilled colleagues
- Participate on bonus and benefit programs
Welcome to join the Calliditas Team!