Dyne Therapeutics · 4 hours ago
Director, Clinical Quality Assurance
Waltham, MA
Full-time
Onsite
Director/Executive
$190K/yr - $233K/yr
10+ years expDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products, ensuring global regulatory compliance and driving continuous improvement across functions.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Inform and contribute to audit planning and strategy
Perform and/or coordinate clinical site and vendor audits
Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs
Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends
Support inspection readiness activities and co-host regulatory inspections
Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements
Conduct and/or manage the qualification and oversight of service providers
Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness
Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity
Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings
Support investigational new drug (IND) applications and related correspondence with global regulatory authorities
Qualification
Required
Bachelor's degree in a scientific, allied health, or medical field required
Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience)
Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements
Broad clinical development experience across all phases (Phase I through BLA/NDA)
Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages
Proven experience developing and implementing risk-based clinical quality assurance programs
Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings
Skilled at effectively communicating quality events and outcomes to internal stakeholders
Excellent interpersonal, verbal, and written communication skills
Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines
Flexible and creative problem solver with a proactive mindset
Highly collaborative team player who fosters open communication and cross-functional cooperation
Willingness to travel up to 20% based on business needs
Preferred
Master's degree
Working knowledge of multiple therapeutic areas is a plus
Company
Dyne Therapeutics
Dyne Therapeutics is a developer of targeted therapies intended for serious muscle diseases.
51-200 employees
H1B Sponsorship
Dyne Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (7)
2023 (1)
2022 (3)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Hercules CapitalAtlas Venture
2025-12-09Post Ipo Equity· $402.5M
2025-06-30Post Ipo Equity· $230M
2025-06-30Post Ipo Debt· $100M
Leadership Team
John Cox
Chief Executive Officer
Recent News
2025-12-24
MarketScreener
2025-12-24
2025-12-24
Company data provided by crunchbase