The International QA Director has the responsibility to ensure that Pharmacosmos’ external and outsourced activities comply with Pharmacosmos requirements, applicable rules for good manufacturing and distribution practice (GMP and GDP) and other applicable rules for Pharmacosmos pharmaceuticals and API products. This position has no direct staff reports and is a new position to strengthen the international projects with primary focus on dry form formulation manufacturing, development of new tablet forms for SP-420 in different strengths and for a pediatric formulation. The position will be a part of a team bringing this new drug to the market from early clinical trials to a fully commercialized product intended to be approved in US, EU, Japan and rest of the world. The position will take part of the larger project team involving key persons from different areas in Pharmacosmos Denmark and US. The project is headed up by a dedicated project manager from development responsible for the overall delivery and reporting to the upper management.
The position will be a part of a small international QA director team reporting directly to the VP for Quality and Regulatory Affairs.
The Position is located in Holbaek.
The International Quality Director is responsible for:
The International Quality Director will secure:
The International Quality Assurance Director should preferably meet the following professional skills:
20-25 days a year
Partner Ole Koch
Headquartered in Denmark, Pharmacosmos is a family-owned, international healthcare company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use.
A research-based company, its ongoing R&D programme focuses on improving the lives of patients with iron deficiency with or without anaemia. More than 1 billion people live with iron deficiency anaemia and it is the leading cause of death for an estimated 180,000 people every year. This makes it one of the largest global health challenges of our time.
Pharmacosmos has subsidiaries in US, China, UK, Ireland, Germany, Sweden and Norway and its products are marketed in more than 80 countries around the world. Its manufacturing facilities are approved, among others, by the Danish Medicines Agency and the US FDA.
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