Scholar Rock

Scholar Rock

Sr. Director, Global Quality Control

Cambridge, MA · Director

Sponsorship not specified$245k-$305kDetected 142 days ago
GMPFDA RegulatoryLeadershipMentoring

About the role

  • 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.
  • Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
  • We celebrate diversity and are committed to creating an inclusive environment for all employees.

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.
  • 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.
  • 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.
  • 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).
  • Demonstrated success leading global stability programs, including shelf-life support, data trending, protocol governance, and regulatory commitment execution.
  • Proven ability to lead through influence in a matrixed organization and manage complex external technical relationships with appropriate rigor and accountability.

Nice to have

  • 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.
  • Ensure effective method qualification, validation, transfer, verification, and lifecycle management across outsourced laboratories, including technical troubleshooting and issue escalation.
  • Provide QC leadership for investigations involving OOS, OOT, non-conforming results.
  • 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.

Compensation

  • $245k-$305k

Company info

  • 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.
  • 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.

Equal opportunity

  • Scholar Rock is an Equal Opportunity Employer.
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This listing is sourced directly from Scholar Rock's careers page and normalized into a canonical job model.