---
title: 'Director, Global Quality Control at Scholar Rock'
canonical: 'https://feeny.ai/job/director-global-quality-control-scholar-rock-cambridge-y0kcys765x92'
type: 'job'
last_seen: '2026-09-13'
---

# Director, Global Quality Control at Scholar Rock

- **Company:** Scholar Rock
- **Location:** Cambridge, MA
- **Compensation:** $200k–$240k
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-09-01
- **Last confirmed live:** 2026-09-13
- **Apply:** https://jobs.lever.co/scholarrock/eb4d812b-e3cf-4aea-b53d-a1a6b1ae70ba

## Job description

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 Director of Global Quality Control to support commercial readiness and ongoing commercial QC operations. Reporting to the Sr. Dir Product Quality, this position is a key QC leader responsible for advancing an inspection-ready, globally compliant commercial QC framework within a fully outsourced manufacturing and testing network. This role provides technical and operational leadership for commercial release and stability testing, specification lifecycle management, analytical method lifecycle activities, external laboratory oversight, and QC support for post-approval changes, regulatory commitments, and global market supply.

Position Responsibilities

- 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.

Candidate Requirements

- 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.

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

## About Scholar Rock

## Company Overview
- **One-liner**: Scholar Rock is a biopharmaceutical company discovering and developing selective therapies targeting growth factors for serious diseases with high unmet need.
- **Entity Type**: Public (NASDAQ: SRRK)
- **Headquarters**: Cambridge, Massachusetts, United States
- **Founded**: 2012
- **Founders**: Not publicly available

## Core Business
- **Primary industry**: Biotechnology / Biopharmaceuticals
- **Target customers**: Patients suffering from neuromuscular disorders, cancer, fibrotic diseases, and hematologic conditions; healthcare providers and payers
- **Mission**: “Turning scientific discoveries into a pipeline of investigational therapies aimed at diseases where growth factors play a central role.”

## Products & Services
- **Apitegromab (SRK-015)**: A selective anti‑latent myostatin antibody in Phase 3 for spinal muscular atrophy (SMA). BLA resubmission and U.S. launch anticipated in 2026.
- **SRK‑181**: A selective anti‑latent TGFβ1 antibody for locally advanced or metastatic solid tumors (immuno‑oncology).
- **SRK‑373**: A context‑dependent anti‑latent TGFβ1 antibody for multiple fibrotic indications.
- **SRK‑256**: A selective anti‑RGMc/HJV antibody for hematology indications.
- **Proprietary Platform**: Broad technology for generating monoclonal antibodies that selectively target latent forms of growth factors (TGFβ superfamily).

## Market Standing
- **Valuation/Market Cap**: $2.8 B (as of search date, 2026‑09‑06)
- **Key Metric**: Annual revenue $0 (pre‑commercial); IPO in 2018
- **Notable Investors/Partners**: Not publicly available
- **Growth Signals**: Headcount grew 27.4% YoY to 278 employees; workforce across 7 countries; 20,522 LinkedIn followers (+45.9% yearly); first company to show clinical proof‑of‑concept for a muscle‑targeted treatment in SMA.

## Competitive Advantages
- First‑in‑class platform for selectively targeting latent growth factors (TGFβ superfamily), enabling high specificity and reduced off‑target effects.
- Proven clinical proof‑of‑concept in SMA with apitegromab, a novel mechanism.
- Broad pipeline spanning neuromuscular, oncology, fibrosis, and hematology, with multiple programs in Phase 2/3.

## Strategic Focus
- Advance apitegromab toward regulatory submission and commercial launch in SMA.
- Expand pipeline into cardiometabolic disorders and other growth‑factor‑driven diseases.
- Leverage platform to address historically under‑addressed disease areas.

## Why Work Here
- **Culture**: “Passion for science” and “every voice counts” – a collaborative, trust‑based environment focused on changing patients’ lives.
- **Work Policy**: Hybrid (e.g., Senior Director, Business Analytics in Cambridge, MA) and on‑site roles available.
- **Benefits**: Competitive health/dental/vision plans, life/AD&D insurance, short‑ and long‑term disability, paid parental leave, 401(k) match, financial wellness program, professional development, free parking/transit pass, onsite fitness center, weekly community lunches, peer‑to‑peer recognition.
- **Engineering/Science Culture**: Emphasis on innovation, cross‑functional teamwork, and direct impact on serious diseases.

## Sources
1. [scholarrock.com – Company Overview](https://scholarrock.com/our-company/careers/)
2. [scholarrock.com – Investors & Media](https://scholarrock.com/investors-media/)
3. [scholarrock.com – Pipeline](https://scholarrock.com/our-pipeline/)
4. [jobs.lever.co/scholarrock – Open Positions](https://jobs.lever.co/scholarrock)
5. [linkedin.com/company/scholar-rock – Company Profile](https://linkedin.com/company/scholar-rock)

## Other roles at Scholar Rock

- [Associate Director, Regulatory Strategy](https://feeny.ai/job/associate-director-regulatory-strategy-scholar-rock-cambridge-f1hv61jkjpqp) — Cambridge, MA
- [Associate Director/Director, Medical Operations](https://feeny.ai/job/associate-director-director-medical-operations-scholar-rock-cambridge-2zkcpx861y8d) — Cambridge, MA
- [Senior Engineer II, Downstream Manufacturing Science & Technology (MSAT)](https://feeny.ai/job/senior-engineer-ii-downstream-manufacturing-science-technology-msat-scholar-geqsvbrgdw82) — Cambridge, MA
- [Sr. Director, Head of Clinical Quality Assurance](https://feeny.ai/job/sr-director-head-of-clinical-quality-assurance-scholar-rock-cambridge-5fm8rza72grm) — Cambridge, MA
- [Senior Manager, Contracts](https://feeny.ai/job/senior-manager-contracts-scholar-rock-cambridge-97vvxfdw01z4) — Cambridge, MA
- [Senior Accountant](https://feeny.ai/job/senior-accountant-scholar-rock-cambridge-sdm431e4jv6p) — Cambridge, MA
- [Senior Manager, Veeva Regulatory & Data](https://feeny.ai/job/senior-manager-veeva-regulatory-data-scholar-rock-cambridge-ee5x01hnk5cr) — Cambridge, MA
- [Senior Manager, Veeva Commercial & Data](https://feeny.ai/job/senior-manager-veeva-commercial-data-scholar-rock-cambridge-fnj9gskxvmye) — Cambridge, MA
- [Senior Director, Chief Information Security Officer](https://feeny.ai/job/senior-director-chief-information-security-officer-scholar-rock-cambridge-7ge2fxy8xn9k) — Cambridge, MA
- [Director, Research & Development Technology](https://feeny.ai/job/director-research-development-technology-scholar-rock-cambridge-kx634bmz0eyj) — Cambridge, MA