Global Quality Control Director: Strategy & Compliance

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

Job summary

Dyne Therapeutics is seeking a Director of Quality Control to lead global QC activities from early development through commercialization. The role oversees external laboratories, ensures compliant analytical testing, and drives cross-functional alignment with QA, Manufacturing, and Regulatory teams.

This onsite position is based in Waltham, MA. The candidate will guide method qualification/validation, stability programs, and product expiry decisions, while shaping QC to meet regulatory

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Chemistry, or related discipline; advanced degree preferred.
• 12+ years in Analytical Development and/or Quality Control in GMP-regulated environments.
• 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 biologics and/or small molecules analytical methods; external vendor oversight.

Responsibilities

• Defines and executes the strategic vision for the QC function to support clinical and commercial programs.
• Leads and develops QC personnel, including oversight of training and performance.
• Oversees external QC laboratories, testing execution, data analysis, and COA issuance.
• Partners with QA, Manufacturing, CMC, Regulatory Affairs, and Project Management to align goals.

Skills

Quality Control leadership

External laboratory oversight

cGMP knowledge

Analytical methods

Team leadership

Education

Bachelor’s degree in Biology/related

PhD in Chemistry or Analytical Chemistry

Tools

SEC

AEX

RP-HPLC

CE-SDS

icIEF

ELISA

Job description

Dyne Therapeutics is seeking a Director of Quality Control to lead global QC activities from early development through commercialization. The role oversees external laboratories, ensures compliant analytical testing, and drives cross-functional alignment with QA, Manufacturing, and Regulatory teams.

This onsite position is based in Waltham, MA. The candidate will guide method qualification/validation, stability programs, and product expiry decisions, while shaping QC to meet regulatory