Director, Quality Control

Dyne Therapeutics; Waltham (MA); On-site; USD 190,000 - 230,000; Full time

Job summary

Dyne Therapeutics, based in Waltham, MA, is seeking a Director of Quality Control to lead global QC activities from development through commercialization. The role oversees external laboratories, ensures cGMP compliance, and aligns regulatory submissions with program timelines to enable product disposition.

The successful candidate will drive QC strategy, manage teams, and partner with QA, Manufacturing, Regulatory, and Project Management to support DS/DP specifications and stability programs.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Chemistry, or related discipline; advanced degree strongly preferred.
• 12+ years of experience in Analytical Development and/or Quality Control within GMP environment.
• Strong expertise in analytical techniques (SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA).
• Deep knowledge of cGMP regulations and global guidance (FDA, ICH, EU).
• Experience with external QC laboratories and vendor performance.
• Experience with CMC regulatory submissions from IND through BLA and commercialization.

Responsibilities

• Defines and executes the strategic vision for QC to support clinical and commercial programs.
• Establishes structure, capabilities, and processes to support growth and future commercialization.
• Leads QC personnel, training, performance, and development.
• Oversees external QC laboratories, testing, data analysis, and COAs.
• Tracks lab performance metrics to drive partner accountability and improvement.
• Leads analytical troubleshooting with contract labs.
• Ensures alignment of partners with program timelines for product disposition.
• Reviews and approves QC SOPs and validation reports.

Skills

Analytical Development

Quality Control

GMP

Regulatory

Leadership

Cross-functional

Strategic thinking

Problem solving

Communication

Negotiation

Education

Bachelor’s degree in Biology/ Biochemistry/ Chemistry

PhD in Chemistry/ Analytical Chemistry

Tools

SEC

AEX

RP-HPLC

CE-SDS

icIEF

ELISA

Job description

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 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.

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.

Responsibilities

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.

Qualifications

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.

Pay Range

$190,000 - $230,000 USD

Equal Employment Opportunity

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.