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Director of Quality (QP/RP) en Scholarrock

Scholarrock · Dublin, Irlanda · On-site

$190,000.00  -  $260,000.00

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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.

Position Responsibilities:

  • Quality Systems & Leadership:
  • Assist in the development and maintenance of the QMS in accordance with EU GMP EudraLex Vol. 4 and EU GDP (2013/c 343/01) requirements. 
  • Provide quality oversight for operations and ensuring product quality, compliance and batch certification/release.
  • Participate in Quality Management Review meetings, ensuring effective communication of quality metrics and continuous improvement initiatives.
  • Ensure effective stakeholder engagement and collaborate cross functionally to achieve quality objectives.
  • Ensure effective mechanisms of escalation are in place to effectively manage communication of significant quality events.
  • Qualified Person (QP) in accordance with Directive 2001/83/EC, Article 51:
  • Act as Qualified Person in accordance with EU GMP, including explicit compliance with Annex 16 and the terms of the Marketing Authorisation.
  • Certify batches for release to the market or for export, ensuring that products are manufactured and tested in compliance with EU GMP, the marketing authorisations and relevant legislation.
  • Ensure third-party manufacturing sites and testing laboratories are appropriately qualified, audited and compliant. 
  • Provide QP oversight for importation activities, ensuring appropriate testing, certification and documentation for imported medicinal products.
  • Maintain knowledge and qualifications status in accordance with HPRA QP registration requirements.
  • Exercise independent authority for batch disposition and escalation of quality and compliance risks to senior management.
  • Responsible Person in accordance with EU GDP Guidelines Section 2:
  • Ensure wholesale distribution operations comply with GDP principles and the company’s WDA.
  • Ensure the initial and on-going verification of suppliers and customers of medicinal product is in scope of the WDA. 
  • Oversee the maintenance of distribution records, recall readiness, complaint management and falsified medicines reporting. 
  • Support training of staff involved in GDP operations and monitor on-going competence.
  • Act as point of contact with the HPRA for GDP-related matters.
  • Ensure GDP-related deviations, complaints, recalls and CAPAs are appropriately assessed and managed.
  • Global Quality Oversight:
  • Provide quality oversight for global supply chain activities under the remit of the Irish entity.
  • Ensure all outsourced activities are governed by effective Quality Technical Agreements and subject to ongoing performance monitoring.
  • Collaborate with U.S. and global Quality counterparts to ensure consistent quality standards, release practices, and escalation pathways across regions.
  • Support alignment of quality processes and practices across global affiliates and Marketing Authorisation Holders.
  • Provide expert input into risk assessments, deviation/CAPA management, annual product quality review, and global quality improvement initiatives.
  • Compliance, Inspection & Audits and Continuous Improvement:
  • Serve as the primary point of contact for HPRA inspections and EU regulatory interactions related to the Irish entity.
  • Ensure on-going HPRA inspection readiness for both the WDA and MIA, participate in inspection and response preparation activities.
  • Ensure inspection readiness and timely closure of CAPAs, including effectiveness checks and documented follow-up.
  • Lead and participate in internal audits and self-inspections, ensuring continuous improvement and compliance.
  • Oversee the investigation and closure of deviations, CAPAs, complaints and change controls. 
  • Drive risk-based quality improvement projects and promote a strong compliance culture across operations. 
  • Monitor changes in GMP/GDP legislation, HPRA guidance and ICH standards implementing updates as required.

    • Candidate Requirements:

  • Degree in Life Sciences, Pharmacy or related discipline.
  • Eligible to act as Qualified Person (QP) and Responsible Person in Ireland.
  • Demonstrated experience with both GMP (MIA) and GDP (WDA) virtual manufacturing and wholesale environments. 
  • Strong working knowledge of GxP regulations, international quality standards and distribution requirements.
  • Substantial experience acting as a QP for biologics and/or sterile products preferred.
  • Demonstrated experience supporting HPRA and/or EMA inspections.
  • Strong knowledge of EU GMP, GDP, Annex 16, and virtual/outsourced manufacturing models.
  • Ability to operate independently and confidently in a regulator-facing role.
  • Hybrid role to be based in Ireland, with availability to support on-site regulatory inspections and partner oversight.
  • Strong communication and stakeholder engagement skills.
  • Experience with biologics and sterile manufacturing.
  • Ability to work effectively in a dynamic, fast-paced and global environment.
  • High integrity and a commitment to patient safety and product quality.

    • Additional Information

    Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. 
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