Dyne Therapeutics
Director, Clinical Quality Assurance
Dyne Therapeutics, Waltham, Massachusetts, United States, 02254
Company Overview
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements.
This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities Include
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 elevate 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
Education and Skills Requirements
Bachelor's degree in a scientific, allied health, or medical field required; Master's degree preferred
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
Working knowledge of multiple therapeutic areas is a plus
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
MA Pay Range $190,000—$232,800 USD
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job‑related knowledge, and demonstrated skills.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all‑inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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Role Summary The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements.
This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities Include
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 elevate 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
Education and Skills Requirements
Bachelor's degree in a scientific, allied health, or medical field required; Master's degree preferred
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
Working knowledge of multiple therapeutic areas is a plus
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
MA Pay Range $190,000—$232,800 USD
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job‑related knowledge, and demonstrated skills.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all‑inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
#J-18808-Ljbffr