As Quality Director – Partner & Systems at Calliditas, you are responsible for establishing, maintaining, and continuously improving the global Quality Management System (QMS) in compliance with relevant laws and regulations. Furthermore, your role involves providing Quality Management oversight, leadership, expertise, reviews and, as required, Quality approvals within the establishment and ongoing cooperation with Calliditas’ partners. In this role, you will actively contribute to the development and execution of Calliditas’ strategy, objectives, and targets.
You are also tasked with ensuring a state of control and compliance within Calliditas’ QMS, along with adherence to applicable GxP standards, authorizations and internal policies. As part of this responsibility, you actively identify and communicate compliance issues or risk and take the lead in developing and executing action plans to address these concerns or mitigate potential risks. Your role involves supporting and leading the writing, review, and approval of governing documentation related to Quality Management of Calliditas’ medicinal products, as well as support and lead audits of partners, suppliers and other third parties.
Reporting directly to the VP of Quality Assurance, you work closely with Calliditas’ functional heads and process owners, leading alliance management of Calliditas’ partners and development, supply and distribution of Calliditas’ medicinal products.
Calliditas is looking for an individual with a strong understanding of the pharmaceutical industry who is eager to further develop their skills within a rapidly growing international company.
The ideal candidate is ambitious and responsible, willing to take ownership of tasks and unafraid to tackle challenges. You exhibit high integrity and leadership maturity, and you value collaboration, are attentive to others, and are enthusiastic about sharing thoughts and ideas with the team. Additionally, you provide support and coaching to your colleagues. You thrive in a cohesive work environment that feels like a family and are committed to working diligently to achieve goals.
You should have the ability to thrive in a fast-paced and dynamic environment with shifting priorities. Your problem-solving skills should reflect innovative thinking and sound decision-making. Moreover, you pay attention to detail and exhibit a structured and efficient work style.
- University degree in relevant applied sciences (e.g., pharmacy, medicine, chemistry, biology, or pharmaceutical, chemical, or biotechnology engineering)
- A minimum of 10 years of experience in quality management, assurance or control, supply chain, alliance management, regulatory affairs, or product/process development in life sciences
- Experience in contract negotiation, partner/supplier management, and performance monitoring in medicinal product-related contexts
- Proficiency in cross-functional collaboration, international leadership, and organizational roles (e.g., line management, project management)
- Lead auditor experience, especially in commercial, manufacturing or clinical quality management
- In-depth knowledge of FDA Regulations, EU Regulations, and ICH Standards
- Strong verbal and written communication skills in both English and Swedish
All applications are handled by Bossanova People Agency.
Calliditas has an exclusive partnership with Bossanova People Agency regarding this recruitment. We kindly request that other external recruitment companies refrain from contacting us & Calliditas about this job posting
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.
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®.
TARPEYO and KINPEYGO® are the first and only treatments approved for IgA nephropathy by the FDA and EMA, respectively.
Calliditas also has a pipeline in orphan-focused indications. 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).
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!