Director, Quality Control

Company Overview:

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .

Role Summary:

The Director, Quality Control leads global Quality Control activities, including oversight of external laboratories supporting analytical testing, release, and stability programs across clinical and commercial stages. Provides strategic direction and operational leadership to ensure compliant, efficient, and high-quality execution of QC activities from early development through BLA and commercialization. Drives cross-functional alignment and external partnership performance while shaping the QC function to meet evolving organizational and regulatory requirements.

This is an onsite role based in Waltham, MA.

Primary Responsibilities Include :

Quality Control Strategy Functional Leadership

Defines and executes the strategic vision for the Quality Control function to support clinical and commercial programs

Establishes organizational structure, capabilities, and processes to support growth and future commercialization

Participates in Pharmaceutical Quality leadership team activities, contributing to functional goals, priorities, and budgets

Leads and develops QC personnel, including oversight of training, performance, and team development

External Laboratory Oversight Analytical Operations

Oversees external QC laboratories, including testing execution, data analysis, and issuance of Certificates of Analysis

Defines, tracks, and trends laboratory performance metrics (e.g., quality, capacity, turnaround time, non-conformances) to drive partner accountability and continuous improvement

Leads analytical troubleshooting efforts in collaboration with contract laboratories

Ensures alignment of external partners with program timelines to enable product disposition

Quality Systems, Compliance Technical Execution

Reviews and approves analytical method qualification and validation protocols and reports

Authors, reviews, and approves stability protocols and reports and supports assignment of product expiry

Supports establishment of critical quality attributes (CQAs) and product specifications for Drug Substance (DS) and Drug Product (DP)

Partners with QA to ensure effective oversight of cGMP QC activities, including change control, deviations, investigations, CAPAs, and batch disposition support

Leads Out of Specification (OOS) and Out of Trend (OOT) investigations

Authors, reviews, and approves QC standard operating procedures

Regulatory, Inspection Readiness Cross-Functional Collaboration

Prepares and reviews analytical CMC content for regulatory submissions (INDs, BLAs) and supports interactions with global health authorities

Participates in regulatory inspections and ensures inspection readiness across QC activities

Collaborates closely with Quality Assurance, Manufacturing, CMC, Supply Chain, Regulatory Affairs, and Project Management to align quality and program objectives

Oversees stability and reference standard programs to ensure compliance with regulatory expectations

Education and Skills Requirements:

Bachelor’s degree in Biology, Biochemistry, Chemistry, or related discipline; advanced degree (PhD) in Chemistry or Analytical Chemistry strongly preferred

12+ years of experience in Analytical Development and/or Quality Control within a GMP-regulated environment

Strong expertise in analytical techniques (e.g., SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA)

Deep knowledge of cGMP regulations and global guidance (FDA, ICH, EU)

Experience with compendial and product-specific analytical methods for biologics and/or small molecules

Demonstrated experience managing external QC laboratories and vendor performance

Experience supporting CMC regulatory submissions from IND through BLA and commercialization

Experience with oligonucleotide therapeutics, mass spectrometry, or bioanalytical assays is a plus

Proven leadership experience, including building and developing teams and driving organizational effectiveness

Strong strategic thinking and problem-solving capabilities with the ability to translate strategy into execution

Excellent interpersonal, communication, and negotiation skills with the ability to influence internal and external stakeholders

Highly collaborative leader who fosters cross-functional alignment and drives results in a fast-paced environment

#LI-Onsite

MA Pay Range

$190,000 $230,00…