Senior Director, Quality Control - GMP & Regulatory Readiness

BioSpace; Waltham (MA); On-site; USD 240,000 - 285,000; Full time

Job summary

Dyne Therapeutics is seeking a Senior Director of Quality Control in Waltham, MA to lead global GMP compliance, inspection readiness, and analytical support for clinical and commercial manufacturing. You will partner with contract manufacturers and cross-functional teams to advance QC strategy and ensure data integrity.

The role requires 15+ years in Analytical Development/Quality Control, strong GMP experience with antibodies and small molecules, and proven leadership in a matrixed environment.

Qualifications

• Bachelor’s degree in biology, analytical chemistry, biochemistry, or a related field.
• Advanced degree in chemistry, analytical chemistry, or a related discipline is preferred.
• 15+ years of experience in Analytical Development and Quality Control, or equivalent, including leadership.
• Strong GMP Quality Control background, including experience with antibodies and small molecules.
• Experience supporting regulatory submissions and inspections, including analytical CMC content.
• Experience leading teams and influencing stakeholders in a matrixed environment.

Responsibilities

• Define and execute the Quality Control strategy in alignment with quality and business objectives.
• Oversee external testing laboratory operations, release and stability testing, and COA issuance.
• Lead regulatory inspections and preparation of analytical content for submissions.
• Develop and maintain drug substance and drug product specifications and stability programs.
• Drive data integrity initiatives, CAPAs, and change control processes.
• Mentor team members and promote a high-performing quality culture.

Skills

Leadership experience

GMP knowledge

Communication skills

Stakeholder management

Matrixed environment adaptability

Education

Bachelor's degree in biology

Advanced degree in chemistry

Job description

Dyne Therapeutics is seeking a Senior Director of Quality Control in Waltham, MA to lead global GMP compliance, inspection readiness, and analytical support for clinical and commercial manufacturing. You will partner with contract manufacturers and cross-functional teams to advance QC strategy and ensure data integrity.

The role requires 15+ years in Analytical Development/Quality Control, strong GMP experience with antibodies and small molecules, and proven leadership in a matrixed environment.