Director of Quality (QP/RP)

Scholar Rock(1 month ago)

HybridFull TimeDirector$213,430 - $281,158 (estimated)Quality Assurance

About this role

The Director of Quality for Scholar Rock Ireland Limited leads the Quality Management System and ensures compliance with EU GMP and GDP requirements across manufacturing, importation, and distribution for the EU supply chain. The role serves as the Qualified Person and Responsible Person for the Irish entity, providing independent quality and regulatory oversight. It acts as the primary quality interface with HPRA and other EU regulators and provides global quality leadership for supply chain operations under the Irish remit. The position is based in Ireland in a hybrid working model, supporting on-site regulatory inspections and partner oversight.

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Required Skills

Quality Management
GMP Compliance
GDP Compliance
Batch Release
Regulatory Oversight
HPRA Liaison
Quality Auditing
Inspection Readiness
Deviation Management
CAPA Management

+14 more

Qualifications

Degree in Life Sciences
Degree in Pharmacy
Eligible Qualified Person in Ireland
Eligible Responsible Person in Ireland

About Scholar Rock

scholarrock.com

Scholar Rock is a biopharmaceutical company focused on the discovery and development of innovative medicines. Using cutting‑edge science and translational research, it advances novel therapeutic candidates from discovery into clinical development to address serious unmet medical needs. The company’s mission is to discover, develop, and deliver therapies that improve people’s lives, combining bold scientific approaches with a patient‑focused commitment.