Director, Pharmacovigilance Quality Assurance

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 Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a 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 at and follow us on X LinkedInand Facebook.

Role Summary:

The Director of Pharmacovigilance Quality Assurance (PVQA)leadsthe quality and compliance of pharmacovigilance activities ensuring adherence to global regulatory standards and company policies. This role encompasses the development and implementation of quality programs conducting audits andmaintainingreadiness for inspections. This rolecollaborateswith cross-functional teams and overseesvendor management while driving continuous improvement in pharmacovigilance processes.This roleleadsthe design and execution of DynesPharmacovigilance Quality Management System (QMS) including policies procedures audits inspections inspectionreadiness and vendor oversightto ensure PV systems and processes meet global regulatory requirements and support high-quality regulatory submissions.

ThisroleisbasedinWalthamMA.

PrimaryResponsibilitiesInclude

• Lead the design implementation and continuous improvement of thePharmacovigilance Quality Management System (QMS) including policies procedures and standards
• Develop and executerisk-based quality planssupporting pharmacovigilance activities across clinical and commercial programs
• Plan conduct and supportinternal and external GVP audits inspections and inspection readiness includingPharmacovigilance System Master File (PSMF)contributions
• Overseequality systems and processes including deviationscorrective and preventive actions (CAPAs)key performance indicatorsKPIs quality indicators and audit tracking/reporting
• Identify assess and escalatequality and compliance risks driving mitigation strategies to support regulatory submissions and patient safety
• Ensure compliance withglobal GVP regulations ICH guidelines and company standards
• Provideexpert guidance onGVP compliance trends and requirementsto internal stakeholders
• Leadvendor qualification oversight and audit readinessfor pharmacovigilance service providers
• Develop and deliverPV training SOPs and policiesin alignment with global regulatory requirements
• Partner cross-functionally (Clinical Development Translational Biomarkers IT) to supportclinical program compliance and sponsor oversightand safety database validation and system compliance (e.g. 21 CFR Part 11)
• Supportglobal regulatory submissionsinteractionsandcorrespondenceincluding IND-related activities
• Advise stakeholders on GVP compliance issues and trends ensuring inspection readiness and co-hosting regulatory audits
• Manage thequalificationof pharmacovigilance service providers ensuring compliance with quality programs and readiness for inspections
• Assess and escalate compliance risks from audit findings focusing on subject safety and data integrity

EducationandSkillsRequirements

• Bachelors degree ina scientificdisciplineadvanceddegree preferred
• 10years in pharmacovigilance with at least 5 years ina PVquality assurancerole (or similar combination of PV and QA experience)
• In-depth knowledge of global pharmacovigilance regulations(e.g. FDA EMA) guidelines(e.g. ICH GVPGxP) and safety reporting requirements
• Broad drug experience across all clinical phases (Phase I to BLA/NDA)
• Strong understanding of GVP Quality for pre-clinical clinical and commercial stages
• Hands-on experience withpharmacovigilance systems andsafety databases including validation audits and compliance assessments
• Proven experience in developing and implementing risk-based clinical quality assurance programs
• Experience leading PVQA audits andinspections andresponding to regulatory findings
• Abilityto conciselypresent quality events to internal stakeholders
• Results-oriented with a focus on settingobjectivesandeffectivelymanagecompeting priorities and dynamic timelines
• Flexible and creative problem-solving skills
• Highly collaborative team player fostering open communication and cooperation
• Excellent communication skills both verbal and written with the ability to present complex information concisely to internal stakeholders.
• Strong problem-solving skills and a results-oriented mindset with the ability to manage competing priorities

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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.