Director of Quality (QP/RP)
Dublin
Description
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
Summary of Position:
The Director of Quality provides strategic and operational leadership for the Quality Management System (QMS) of Scholar Rock Ireland Limited. The role is responsible for ensuring compliance with EU GMP and GDP requirements for all manufacturing, importation, and distribution activities supporting the EU supply chain.
The Director of Quality is responsible for the development, implementation, and continual improvement of the company’s QMS to ensure compliance with EU GMP/GDP requirements and other applicable regulations in support of the operations of Scholar Rock Ireland Limited.
The role acts as Qualified Person (QP) under the company’s Manufacturing and Importation Authorisation (MIA) and as Responsible Person (RP) under the Wholesale Distribution Authorisation (WDA), providing quality and regulatory oversight of all manufacturing, importation, and distribution activities conducted or managed by the Irish entity.
The Director of Quality also provides global quality leadership for supply chain operations falling under the remit of Scholar Rock Ireland Limited, ensuring consistent application of GMP and GDP standards across affiliates, partners, and third-party service providers.
The role serves as the primary quality representative to the HPRA and other EU regulatory authorities and provides independent quality oversight for the Irish legal entity.
About Scholarrock
Scholarrock