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
Top Skills
What We Do
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. For additional information on our guidelines, please visit https://scholarrock.com/community-guidelines/ For more information on how Scholar Rock collects, uses, and shares personal information, please visit: https://scholarrock.com/privacy-policy
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