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Scholar Rock

Posted 3 months ago

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Sr. Director, Global Quality Control

Cambridge, MAOn-siteFull-time

AI Summary

Senior Director of Global Quality Control leads outsourced QC strategy and global QC operations, overseeing external labs, CMOs, and testing partners for release, stability, and compliance across clinical and commercial programs.

About this role

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Summary of Position:

Scholar Rock is seeking an experienced and motivated Senior Director of Global Quality Control. Reporting to the Head of Global Quality, this position is the senior QC leader responsible for establishing and maintaining a phase-appropriate, scalable, and inspection-ready global QC strategy for a fully outsourced development and manufacturing network. This role provides strategic and technical leadership for Quality Control activities executed through external contract laboratories, CMOs, and other testing partners supporting drug substance, drug product, raw materials, in-process, release, and stability programs.

Position Responsibilities

  • Lead the company’s global QC function across a fully outsourced model, with end-to-end oversight of external QC laboratories, CMOs, and contract partners supporting clinical and commercial programs.
  • Define and execute the global QC strategy, serving as the internal QC subject matter expert across analytical control strategy, compendial compliance, specification lifecycle management, and stability.
  • Provide strategic oversight of stability programs, including protocol design, pull schedule governance, data review and trending, shelf-life support, comparability assessments, and post-approval stability commitments.
  • Oversee post-approval specification management, including revision strategy, change assessment, comparability impacts, commitment tracking, and implementation through external partners.
  • Ensure effective method qualification, validation, transfer, verification, and lifecycle management across outsourced laboratories, including technical troubleshooting and issue escalation.
  • Partner with Analytical Development and CMC teams to support method readiness, control strategy development, and phase-appropriate analytical plans for new programs, process changes, and commercialization activities.
  • Provide QC leadership for investigations involving OOS, OOT, non-conforming results.
  • Establish and monitor quality and operational performance expectations for external testing partners through governance forums, metrics, trend reviews, and business process oversight.
  • Author, review, and approve QC-related controlled documents, including specifications, protocols, reports, SOPs, method transfer plans, stability documents, and technical assessments as applicable.
  • Build fit-for-purpose QC systems, governance, and internal capabilities appropriate for a virtual biotech environment, with a focus on compliance, technical rigor, and scalability.
  • Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global regulators).

    • Candidate Requirements

  • BS/MS degree in a scientific discipline; advanced degree (MS or PhD) preferred
  • 15+ years of progressive Quality Control and/or Analytical Sciences experience in biotech/pharma industry (including outsourced operating models), with 7+ years in leadership roles
  • Deep technical expertise in analytical methods supporting biologics and/or other advanced therapeutic modalities, including release, stability, and characterization testing.
  • Strong working knowledge of USP, EP, and JP pharmacopeial requirements, and cGMP, ICH guidance, global regulatory requirements, and inspection readiness for outsourced QC operations.
  • Demonstrated success leading global stability programs, including shelf-life support, data trending, protocol governance, and regulatory commitment execution.
  • Proven experience in specification development, justification, and lifecycle management, including post-approval specification revisions and change implementation.
  • Extensive experience with method transfer, qualification, validation, verification, and troubleshooting across contract testing laboratories and manufacturing partners.
  • Proven ability to lead through influence in a matrixed organization and manage complex external technical relationships with appropriate rigor and accountability.
  • Strong executive presence, sound scientific judgment, and the ability to balance strategic leadership with practical execution.
  • Highly proactive, decisive, and capable of independently managing key initiatives.
  • Engaged people manager committed to building culture as well as mentorship and talent development

    • Skills

    Analytical Method DevelopmentCGMPChange ControlCMC CollaborationComparability AssessmentsData Trending And Inspection ReadinessDocument ControlExternal Partner ManagementICH GuidelinesMethod TransferMethod ValidationMethod VerificationOOS/OOT InvestigationsPolicy And SOP DevelopmentQualification/verification Of Testing MethodsQuality Metrics And GovernanceRegulatory Submissions SupportRelease TestingSpecification Lifecycle ManagementStability Program GovernanceStability TestingUSP/EP/JP PharmacopeiaValidation Lifecycle Management

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