Director, Quality Control

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.

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
• Led and develops QC personnel, including oversight of training, performance, and team development
• 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
• 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)
• Pairs 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
• 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
• Hightly collaborative leader who fosters cross-functional alignment and drives results in a fast-paced environment

Pay Range

$190,000 - $230,000 USD

Company

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).

Connect

Stock Symbol: DYN
Stock Exchange: Nasdaq
Website: https://www.dyne-tx.com/