Scholar Rock Holding Corporation

Director, Global Quality Systems and Compliance

Scholar Rock Holding Corporation • $200K — $245K *
Cambridge, MA 02139Hybrid
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS/MS degree in a scientific discipline.
  • 10-15 years of experience in the pharmaceutical/biotech industry, including 5+ years in leadership roles within Quality or related functions.
  • Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech.
  • Experience designing, optimizing, and scaling Quality Management Systems for commercial operations.
  • Proficiency in digital quality systems like eQMS, Document Management Systems, and Learning Management Systems.
  • Hands-on experience with Veeva Vault preferred.
  • Proactive and decisive in managing initiatives independently.

Responsibilities

  • Support the transition of the global Quality Management System (QMS) to a commercial-ready environment.
  • Optimize core QMS processes to ensure efficiency and scalability for commercial operations.
  • Drive a compliance framework that maintains inspection readiness and meets global regulatory expectations.
  • Enhance the product complaint handling program to manage increased market distribution and product volume.
  • Scale the GxP training program to improve effectiveness and compliance as the organization grows.
  • Lead the validation of GxP computerized systems to ensure data integrity and integration for commercial use.
  • Develop a risk-based supplier quality management program to support commercial manufacturing needs.
  • Implement QMS performance metrics and quality KPIs to drive insights and proactive risk identification.

Benefits

  • Opportunity to shape a global Quality Management System during a critical transition phase.
  • Engagement in high-visibility projects with executive visibility and impact.
  • Exposure to cutting-edge digital quality systems and tools.
  • Work in a dynamic environment that values compliance and innovation.
  • Contribute strategically to commercial manufacturing and distribution readiness.
Full Job Description


Summary of Position:

Position Responsibilities

  • Support global Quality Management System (QMS) transition from clinical-stage operations to a commercial-ready, scalable, and inspection-ready environment.
  • Optimize core QMS processes (change control, deviations, CAPAs, complaints, audits, document control, training, and supplier quality) to ensure they are efficient, phase-appropriate, and scalable for commercial operations.
  • Establish and drive a proactive compliance framework that ensures sustained inspection readiness and supports global regulatory expectations.
  • Strengthen the product complaint handling program, ensuring robust intake, triage, investigation, escalation, and trending processes that can support increased product volume and market distribution.
  • Scale the GxP training program, implementing role-based curricula, improving training effectiveness, and ensuring sustainable compliance as the organization grows.
  • Lead validation of GxP computerized systems (eQMS, LMS, etc.), ensuring systems are fit-for-purpose, integrated, and capable of supporting commercial operations, with strong data integrity controls.
  • Build and mature a risk-based supplier quality management program, ensuring suppliers are qualified, monitored, and capable of supporting commercial manufacturing and distribution requirements.
  • Support the implementation of QMS performance metrics and quality KPIs, enabling data-driven insights, proactive risk identification, and executive-level visibility.
  • Support internal audit program, focused on identifying systemic gaps and ensuring readiness for commercial inspections.


Candidate Requirements

  • BS/MS degree in a scientific discipline.
  • 10-15 years of experience in the pharmaceutical/biotech industry, with 5+ years in leadership roles within Quality or related functions.
  • Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech manufacturing and development.
  • Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution.
  • Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability.
  • Hands-on experience with systems such as Veeva Vault is preferred.
  • Highly proactive, decisive, and capable of independently managing key initiatives.


$200,000 - $245,000 a year

About Scholar Rock Holding Corporation

Scholar Rock Holding Corporation is a clinical-stage biopharmaceutical company that focuses on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. The company's proprietary platform technology is based on the use of growth factor-binding proteins to selectively inhibit the activation of these signaling pathways in a variety of tissues. Scholar Rock's lead product candidate, SRK-015, is a highly specific inhibitor of the activation of the growth factor myostatin, which is involved in the regulation of muscle mass. The company is headquartered in Cambridge, Massachusetts and was founded in 2012.
Learn more about Scholar Rock Holding Corporation
Size
145 employees
Market Cap
$411.3 million
Industry
Pharmaceuticals & Biotech
Net Income
-$86.4 million
Founded
2012
5 Year Trend
+118.4%
Revenue
$15.4 million
NASDAQ
SRRK
* Ladders Estimates

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