ApplyBlast uses AI to match you with the right jobs, tailor your resume and cover letter, and apply automatically so you can land your dream job faster.

Features

Auto Apply Resume Optimizer Cover Letter Optimizer Interview Prep

Company

Social Media

Need Help?

team@applyblast.com

Director, Pharmacovigilance Quality Assurance at Dyne Therapeutics - ApplyBlast

Director, Pharmacovigilance Quality Assurance

Dyne Therapeutics

5 months ago

4.1 on Glassdoor

Waltham, MA

Onsite

Full Time

Senior

0 applicants

View Job Listing

Apply to 100+ jobs

About this role

Director of Pharmacovigilance Quality Assurance (PVQA) at Dyne Therapeutics leads the quality and compliance of pharmacovigilance activities, ensuring adherence to global regulatory standards and company policies. This role involves developing and implementing quality programs, conducting audits, and maintaining readiness for inspections. The role collaborates with cross-functional teams and oversees vendor management while driving continuous improvement in pharmacovigilance processes.

Responsibilities

Lead the design, implementation, and continuous improvement of the Pharmacovigilance Quality Management System (QMS)
Develop and execute risk-based quality plans supporting pharmacovigilance activities across clinical and commercial programs
Plan, conduct, and support internal and external GVP audits, inspections, and inspection readiness, including Pharmacovigilance System Master File (PSMF) contributions
Oversee quality systems and processes, including deviations, corrective and preventive actions (CAPAs), key performance indicators (KPIs), and audit tracking/reporting
Identify, assess, and escalate quality and compliance risks, driving mitigation strategies to support regulatory submissions and patient safety

Skills

Qualifications

Bachelor’s degree in a scientific discipline, advanced degree preferred10+ years in pharmacovigilance, with at least 5 years in PV quality assurance role (or similar combination of PV and QA experience)In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA), guidelines (e.g., ICH, GVP, GxP), and safety reporting requirementsBroad drug experience across all clinical phases (Phase I to BLA/NDA)Strong understanding of GVP Quality for pre-clinical, clinical, and commercial stages

About Dyne Therapeutics

dyne-tx.com

Headquarters

Waltham, Massachusetts, United States

Company Size

51-200 employees

Founded

2018

View Profile

Dyne Therapeutics is a biotechnology company developing nucleic acid–based therapies for genetically driven neuromuscular diseases. Leveraging its proprietary FORCE™ platform, Dyne aims to address the root cause of disease and deliver functional improvement for people living with conditions such as Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), and facioscapulohumeral muscular dystrophy (FSHD). The company advances a pipeline of therapeutics from discovery through clinical development with the mission of transforming the lives of patients with rare neuromuscular diseases.