Who we are:
This is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives. In the U.S., the company markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, the company is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.
The impact you will make:
This company is searching for a dynamic Manager GMP QA – Clinical to join our growing QA team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Manager GMP QA Clinical will be responsible for supporting and maintaining high quality levels on Drug Substance, Drug Product, packaged Drug Products and finished goods by Contract Manufacturing Organizations (CMOs). This Quality Assurance professional must possess strong leadership skills in order to provide support to the QA Clinical team, and will assure the company, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing and distribution of products used for investigational clinical trials through commercial phases comply with cGMPs and standards as well as regulations of applicable authorities. This role will report to the Associate Director, GMP Quality Assurance and be a member of the GMP clinical group.
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