Global Director, Quality Control & Compliance

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, 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.