Lead and manage key elements of Scholar Rock’s commercial QC function across a fully outsourced model, with direct oversight of external QC laboratories, CMOs, and contract partners supporting commercial drug substance, drug product, raw material, in-process, release, and stability testing.
Support execution of the global commercial QC strategy, serving as an internal QC subject matter expert for commercial analytical control strategy, compendial compliance, specification lifecycle management, stability, and inspection readiness.
Provide oversight of commercial stability programs, including protocol governance, pull schedule adherence, data review and trending, shelf-life support, annual stability commitments, comparability assessments, and post-approval stability requirements.
Manage commercial specification lifecycle activities, including implementation of approved specifications, post-approval revisions, change assessments, market-specific requirements, comparability impacts, and coordination with Regulatory Affairs and external partners.
Ensure effective lifecycle management of commercial analytical methods, including validation maintenance, transfer, verification, method performance monitoring, troubleshooting, and change implementation across outsourced laboratories.
Partner with Manufacturing, Supply Chain, Regulatory Affairs, Analytical Development, MSAT, and Quality Assurance to support commercial lot release, global market supply, process changes, comparability assessments, and regulatory filing commitments.
Provide QC leadership and technical support for commercial investigations involving OOS, OOT, atypical, and non-conforming results, ensuring timely resolution, scientifically sound conclusions, and appropriate CAPA or change control actions.
Monitor quality and operational performance of external testing partners through governance forums, metrics, trend reviews, deviation and CAPA oversight, release cycle-time performance, and business process management.
Author, review, and approve commercial QC-related controlled documents, including specifications, stability protocols and reports, method transfer and validation documents, SOPs, technical assessments, annual product quality review inputs, and regulatory commitment deliverables.
Contribute to fit-for-purpose commercial QC systems, governance, and internal capabilities appropriate for a virtual biotech environment, with a focus on compliance, operational discipline, data integrity, and scalability.
Collaborate with the Head of Quality and cross-functional partners to ensure commercial QC operations remain aligned with corporate goals, patient supply needs, customer expectations, and global regulatory obligations, including FDA, EU, PMDA, Swissmedic, and other health authorities.
BS/MS degree in a scientific discipline; advanced degree preferred.
10+ years of progressive Quality Control and/or Analytical Sciences experience in the biotech/pharma industry, including significant experience supporting commercial GMP products and outsourced operating models; prior people leadership or matrix leadership experience preferred.
Strong technical expertise in analytical methods supporting biologics and/or other advanced therapeutic modalities, including commercial release, stability, characterization, and compendial testing.
Strong working knowledge of USP, EP, JP, cGMP, ICH, data integrity, global market release expectations, and inspection readiness requirements for commercial QC operations.
Experience supporting commercial stability programs, including shelf-life support, data trending, protocol governance, annual commitments, and post-approval stability requirements.
Experience with commercial specification implementation, justification, market-specific requirements, lifecycle management, post-approval revisions, and change implementation.
Experience with commercial method transfer, validation maintenance, verification, performance monitoring, and troubleshooting across contract testing laboratories and manufacturing partners.
Demonstrated ability to support commercial lot release, regulatory commitments, annual product quality review inputs, inspection preparation, and health authority inspection responses.
Ability to lead through influence in a matrixed organization and manage complex external technical relationships with appropriate rigor, urgency, and accountability.
Strong communication skills, sound scientific judgment, and the ability to balance technical leadership with practical commercial execution.
Highly proactive, organized, and capable of independently managing key initiatives in a fast-paced commercial readiness and launch environment.
Engaged leader committed to collaboration, mentorship, and building a strong commercial quality culture.
