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New · posted Oct 15

Scholar Rock · Biotechnology

Director, Global Quality Control

  • Cambridge, MA
  • On-site
  • Full-time
  • Director
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EmploymentFull-time
Deadline

Open until filled

The role

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.

Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.

As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical 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 about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.

What you need

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.
  • What you'll do

  • 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.
  • Pay

    $200,000 – $240,000 a year

    Employer provided
    How this compares

    Where you'll work

    Cambridge, MAOn-siteOpen in Maps (opens in a new tab)

    More jobs in Cambridge, MA
    Equal opportunity, accessibility and legal noticesScholar Rock's statements, word for word

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

    Job intelligence

    The context around this role

    Live data · October 15, 2026

    Salary intelligence

    How the pay compares

    This role's midpoint is 11% above the US median for Quality Control roles at this level.

    This roleEmployer provided

    $200,000 to $240,000 a year

    Director roles in Massachusetts7 roles publishing pay

    Middle half $207,000 to $243,750, median $220,000

    Director roles in the US25 roles publishing pay

    Middle half $186,000 to $240,000, median $198,500
    Annual base pay
    Annual base payLowMedianHigh
    This role$200,000—$240,000
    Massachusetts$207,000$220,000$243,750
    All US$186,000$198,500$240,000

    This role: Scholar Rock's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.

    Career trajectory

    Where this role sits in Quality Control

    The general path across 275 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Scholar Rock's own promotion track.

    1. Earlier

      Associate & Specialist

      Often: Quality Inspector · Quality Control Inspector

      $60K median149 open
    2. Earlier

      Senior & Principal

      Often: Scientist, Quality Control · Senior Scientist, Quality Control

      $95K median70 open
    3. One step back

      Manager

      Often: Quality Control Manager · Manager Quality Control

      $127K median31 open
    4. This role

      Director

      Often: Associate Director, Quality Control · Senior Director, Quality Control

      $199K median25 open

    Skills DNA

    What this role leans on

    How many of the posting's 5 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

    GMP and compliance: 3 linesLab testing and methods: 3 linesDocumentation and SOPs: 1 lineInvestigations and CAPA: 1 lineValidation and qualification: 2 linesRegulatory submissions: 2 linesQuality systems and risk: 1 lineData and digital systems: 2 linesCollaboration and leadership: 4 linesGMPLab testingDocumentationInvestigationsValidationSubmissionsQuality systemsData systemsTeamwork
    • Collaboration and leadership4
    • GMP and compliance3
    • Lab testing and methods3
    • Validation and qualification2
    • Regulatory submissions2
    • Data and digital systems2
    • Documentation and SOPs1
    • Investigations and CAPA1
    • Quality systems and risk1

    Company hiring pulse

    Scholar Rock on Regulatory Jobs

    4
    Open roles
    4
    Distinct roles
    1
    Locations

    By discipline

    • Regulatory2 50%
    • Quality2 50%

    By level

    • Director3 75%
    • VP & Executive1 25%
    See all 4 Scholar Rock roles

    More roles at Scholar Rock

    Similar Quality Control roles elsewhere

    Director, Global Quality Control at Scholar Rock

    Open until filled. $200K–$240K a year, employer provided.

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      Director, Global Quality Control at Scholar Rock — Cambridge, MA | Regulatory Jobs